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Who we are

Xendo is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare. Thanks to our multi-disciplinary, knowledge-driven approach, Xendo can deliver a broad palette of services to the life sciences industry, applying the right colour to projects we participate in. For over 25 years we have successfully completed thousands of national and international assignments for start-ups as well as for the largest, established multinational companies and organisations. Over 230 experienced and highly educated professionals offer their expertise ranging from strategic advice and project management to auditing, operational support, and training; providing a full-colour spectrum.

Our clients

The spectrum of our fields of expertise is as broad as the range of clients we work for, enabling us to cater to the varied needs and wishes of the Life Science industry. We bring our palette of services to companies, ranging from start-ups to multi-national organizations, to provide them with robust solutions. Whether they are a (bio)pharmaceutical or medical device company, a hospital or a pharmacy, a manufacturer or a laboratory, we match their colour.

10-01-2018
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#How to organize a Kaizen (Lean Improvement Workshop)

Kaizen: The Japanese term commonly used for lean improvement workshops. Its meaning expresses what it’s all about: change for the better.

In life sciences, we tend to associate change with change control, which is usually justified because there are plenty common reasons why you need to be in control of every detail. But most of the time we don’t really change anything significantly at all because it’s ‘complicated’ and we go on like before.  In lean, change implies improving. Measuring and demonstrating success as you move on and leaving your current state behind for a new and improved one. The Kaizen specifically has proven itself in many different situations and in many businesses and has the very beneficial side-benefit that people feel heard, engaged and empowered.

For example, taking a number of people to one of their warehouses to "go see what’s actually going on there". They will probably experience that the people who actually work there are surprised when asked what could be improved. This is exactly the essence of Kaizen: not talking about but with your staff.  

What to improve

So to get started. The first step is identifying the area you want to improve on, or in lean terminology: define the problem. There’s plenty of formal tools to make the best choice like value stream mapping.  For instance, creating a complete map following a biopharmaceutical product including the receipt of materials, upstream and downstream processing, aseptic filling, release, and shipment to a customer. This map could show you that something like the water production is the actual bottleneck you’ve been looking for (and now you can improve it). Or it may be the time you need for batch record review or product release. Conclusions like these are usually the result of a Kaizen and are fully data-driven and, therefore, (most of the time) fully supported by the whole team. You can also brainstorm with a group of people and pick one improvement project. Most of the time people actually already know very well which areas can be improved on. Data-driven conclusions may be different from team-based intuition though, obviously.

Secure a sponsor

The next step is identifying your sponsor. If there is none who wants to support you, stop. Basically, there’s no way of organizing a proper Kaizen without sponsorship. Let’s say the event/deviation handling process in a packaging department needs to be improved and the involved Quality Officer doesn’t have time for the Kaizen.  As a result, he or she isn’t very likely to be engaged and in all probability not the most likely person to agree on the proposed improvements. Therefore, you need a sponsor to make sure that every stakeholder actively participates in the event and facilitate a unanimous agreement.

Prepare prepare prepare

After having made sure there is a sponsor it’s your role as facilitator to actually organize the Kaizen. Preparation is key, so agree with your sponsor on things like the definition of the problem, the scope of the Kaizen, would be considered a successful outcome, who’s on the team and the planning. Once these aspects are all settled, you can proceed with data collection.

Start with a plan and try to balance between the needed data and the effort to collect it. This depends mostly on what you want to improve, or in lean: what is problem? If you want to improve the workplace, like the warehouse, for example, observation is your best friend, in a QA release process data collection is more likely the preferred route and in other cases, you might want to focus on material movement. More generally, it may even be refreshing to actually observe what people are doing on their computer.

The Kaizen

At last, the day of your Kaizen has arrived. Make sure that all stakeholders show up and ask your sponsor for help to assure this. These sessions get cancelled occasionally simply because people don’t show up. At least you could tell yourself you’ve defined your first problem if that’s the case.

Your role as a facilitator is key during the Kaizen and you should try to focus on keeping the process going as planned. DMAIC is a very helpful tool here because you’ve already agreed with your sponsor upon the problem, scope, timelines, team, and Kaizen; thus, you already completed D(efine) and because you collected data, you also completed M(easure).



The kaizen is all about direct observation:  M(easure) and determine the root causes and complete the A(nalyses).  Flip-overs and post-its are most useful to support the analyze phase, e.g. to map the process and to prepare a fishbone, a cause and effect diagram which helps to identify root causes by visually displaying the many potential causes for a specific problem or effect.

To keep the process on track is one thing, to keep people on track is a completely different ball game:

  • People can become frustrated with each other in which case you’ll have to address this to some extent, otherwise people get disengaged.
  • Sometimes the subject matter experts seem to know everything about the topic at hand and tend to dominate team discussions. Unfortunately, there is a lot of “I think that”, “I believe that” or boldly “This is how it works” behavior in many companies. And because of this, you will need the data you previously collected to either confirm or reject statements.

Question, question, question and conclude. Make sure that everyone is heard and guide the entire group towards one eventual, consensual conclusion. Other “tools” you definitively need are enthusiasm, energy and humor.

In the traditional approach, all stages are done in five days but it depends very much on the company whether this is necessary or even realistic. You may also choose to end the Kaizen with root causes and solutions identified. In that case, implementation and control become part of business “as usual”.

Evaluation of the Kaizen

Make sure you get tangible and sustainable results. That’s critical. For sure, a properly executed Kaizen boosts team morale, but the hard work starts afterward. And this is all about project management and implementation. The reward, however, is an improved process with tangible results, e.g. errors decreased by 30%, lead time reduced with 40% and yield increased by 10%. And when the team experiences that their daily work has become easier, you can count on it that they won’t be able to wait for the next Kaizen to start.

Tip: If you’d like to experience Lean Six Sigma yourself have a look at our Lean Game of have a look at the Yellow and Green Belt training we provide with the Biotech Training Facility.

Blog by: Marc Stegeman - Certified Black Belt at Xendo

09-01-2018
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#Meet us at Innovation for Health 2018

XENDO BIKE RAFFLE

Like last year, we will also be organising a raffle for one of our customized Xendo VANMOOF bikes! We are looking forward to meeting you there and don't forget to hand in your ticket at our booth!

INNOVATION FOR HEALTH 2018

Innovation for Health is the premier event on healthcare innovations in the Netherlands. It provides a unique opportunity to meet leading innovators, to catch up on the latest trends, to present cutting-edge innovations and to engage leaders and decision makers in healthcare innovation. Innovation for Health features renowned speakers, displays high impact innovations, highlights best practices and demonstrates inspiring developments in healthcare. By bringing together key players and stakeholders across the healthcare & Life Sciences spectrum, and fostering dialogue between research, markets, and policy makers, the event aims to contribute to the future of sustainable healthcare.

More info: https://www.innovationforhealth.nl/

19-12-2017
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#Facing the challenges in clinical study vendor management

Last year, announcements appeared on the FDA, EMA, and  WHO websites, that during regulatory inspections of a clinical contract research organization (CRO) in India serious violations were identified in the conduct of bioequivalence and bioavailability studies.

The outcome of these inspections didn’t just seriously impact the CRO, but also the pharmaceutical companies that subcontracted this CRO.

 “The inspection found significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples..” “the sponsor […] must repeat the bioequivalence/bioavailability studies […] at an acceptable alternate study site.” FDA, April 2016

“EMA recommends suspension of medicines over flawed studies…” “Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU.” EMA, July 2016

 


Risks in vendor management

Present-day clinical studies are increasingly complex, more globalised, and making use of new technologies. As a result, vendors are often highly specialised and pharmaceutical companies (Sponsors) make use of many different vendors in one clinical study. In turn, these vendors often subcontract activities to third party vendors. Sponsors should understand that the use of all those vendors and their subcontractors can be very risky because if one of them fails to be compliant, it can have disastrous consequences for the development of your product.

According to Good Clinical Practice (ICH E6, section 5.2.1), the Sponsor always remains ultimately responsible for the quality and integrity of a study. In the revised ICH E6 (section 5.2.2) it’s stated that Sponsor oversight is not just limited to the vendors they contract, but it also includes the vendor’s third parties.

Some examples of risks in vendor management that might seem familiar:

  • Your company has a list of approved vendors, but… under time pressure, because it was requested because they know the vendor… the study team decides to contract an unapproved vendor or an approved vendor for unapproved services.
  • Your qualified vendor decides to change procedures or one of their vendors without notifying you, the contract giver. This may not seem like a big deal, but what if this change involves critical study activities or software?
  • During the vendor qualification audit, everything looked perfectly fine, but now your vendor doesn’t perform as expected... Serious breaches aren’t escalated, deadlines are missed, overall quality is low… 
  • Are we using Sponsor procedures, vendor procedures, or a combination? Confusion about the applicable procedures can lead to an inconsistent approach to study execution (document management, monitoring, reporting of deviations, etc.) and may finally lead to significant quality issues.
  • Use of different vendors does not only complicate the clinical study execution and (essential document) management. It may also lead to additional data integrity risks. Are you sure that clinical study data collected in different systems finally end up in one location? Are data still reliable when they are transferred from one system to another? Is a reliable analysis of all study data possible during or at the end of the study?

Mitigating the risks

Quality agreements between Sponsor and vendors to document the responsibilities and expectations to ensure the quality of a study are quite common nowadays. Sometimes it’s already part of the contract. But does this give the assurance, that there is a robust quality system in place for your clinical study and will it make sure you don’t face any surprises at some point during or even after the study?

Risks can be further mitigated by a carefully thought-out vendor oversight approach, considering the following aspects:

Formalise your vendor management approach.

Standardising your processes in selection, qualification, contracting, managing and even ending collaboration with vendors can support your company in adequate vendor oversight.  Assign a vendor manager or vendor management team, which can support your company in keeping vendor oversight. A vendor manager can manage the contracts, interact with quality assurance, and be involved in issue/conflict management.

Don’t underestimate the importance of good communication lines (and trust).

Make sure there is a detailed Sponsor-vendor and/or vendor-vendor communication plan in place. Open and transparent communication is essential for smooth execution, prompt handling in case of issues and a reliable study outcome. A relationship built on trust is essential. This is a two-way process: The vendor should be transparent and share potential issues; the contract giver should establish an open environment. Immediate repercussions will work counterproductive. Instead, focus on an action plan to mitigate any risks and improve any processes.

Vendor qualification and requalification are more than ‘just’ an audit.

  • In addition to auditing the vendor’s quality system, competencies and qualifications, experience and resources, have you considered the following? Try to assess the ‘soft’ aspects of vendor quality, such as communication, reliability, collaboration and quality awareness (the quality culture). Not easy to objectify, but you may have a look at repeat business, staff turnover, quality objectives, visibility of leadership, and accessibility to staff during an audit.
  • Assess vendor continuity. In other words, are you sure that the vendor still exists in a few years? Are there any signs of potential acquisitions or mergers, which could potentially influence the commitment of the vendor to your company?
  • Invite a subject matter expert to accompany the auditor. The assigned auditor may not have the in-depth knowledge to assess certain aspects of the considered services. If necessary, involve the Information Technology department or consider to hire a GxP IT auditor.

Consider the potential risks in the combination of vendor activities and systems.

Don’t only consider the potential risks at the level of individual vendors, but also ensure adequate oversight of and assess potential risks in the entire chain of processes and data, from vendor to vendor, from vendor to sponsor. A systematic quality (risk) management approach will finally ensure the integrity of the entire clinical study.

 

Conclusion

When activities are outsourced, the most important task of a Sponsor is to keep good oversight, both by overseeing the individual vendors and by looking in a more systematic way at the use of different vendors in one study. Adequate vendor oversight could avoid issues, which may have any impact on the integrity of the entire study.

Blog by: Henrieke de Bie - Senior Consultant at Xendo

12-12-2017
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#Brexit Life Sciences Highlights

Below you'll find the highlights that we have selected for you regarding regulatory, pharmacovigilance and quality related matters in the Life Sciences industry in a chronological order


The Netherlands welcome EMA, 20-11-2017 - GENERAL

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

Read more.


QP Role gets abolished in the UK, 20-11-2017 - QUALITY MANAGEMENT / QP

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

Read more.


UK to Develop own Eudravigilance System, 20-11-2017 - PHARMACOVIGILANCE

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

Read more.


New legislation regarding orphan designation following Brexit, 20-11-2017 - REGULATORY AFFAIRS

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

Read more.


05-12-2017
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#SERIALISATION AND UDI: 4 REASONS TO START TODAY

In recent years, new European legislation on traceability of medicinal products and medical devices was introduced to guarantee patients’ safety and to avoid fraud. Depending on the industry in which you work, you might have heard more of either Serialisation or UDI (Unique Device Identification). Below we will mention the difference between them. Although the terminology is somewhat different for medicinal Products and for medical devices, in both cases, this is about traceability. And to be precise, it is about track (where the product is now) and trace (where the product came from).

In this blog, we will explain why we advise you - as a medical devices supplier, a medicines supplier or as a logistics service provider - not to wait much longer and start implementing unique identification to take advantage of traceability.

The benefits of traceability

Legislation is not the only reason to implement unique device identification. Traceability has a significant impact on the efficiency of your own and your customers’ operational processes. Traceability is actually nothing new. In many other industries, logistical efficiency is crucial and for years, organisations have been ‘tracking and tracing’ their products with unique identifiers.

For healthcare institutions and pharmaceutical wholesalers, working ‘lean’ is becoming the new standard. For example, if your products do not have machine-readable barcodes, institutions might not purchase your products, as being able to scan all products, benefits them in many respects. Think of: having all relevant data available as soon as a product arrives, having insight of your stock levels, constantly knowing where it is or getting an alert when the expiration date is within e.g. a year. With traceable products, you are better prepared for your customers’ requirements and, of course, for your own efficiency improvements.

4 reasons to start today

As the legislation applies as of February 2019 (for medicines) and May 2020 (for medical devices1), you might think you still have time. But consider to start yet for the following reasons:

  1. Efficiency. Just because of the fact that efficiency is of increasing importance to you and your customers, traceability is recommended.
  2. Implementing traceability might require some significant organisational adjustments, think of:
    • Redesign of packaging and labeling
    • Adjustments to packaging lines and automation systems
    • Documentation of adjusted packaging specifications and procedures including getting approval for them
    • Validation of new or modified packaging processes, equipment, and IT systems.
  3. It is better to avoid rushing into (flawed) decisions. In case you need advice or support to design a new or modified process, the farther the deadline, the more time you have to consider your options.
  4. Practice in the United States has shown, that even with a segmented implementation and with a wealth of experience with UDI, manufacturers have difficulty meeting the deadlines.

The difference between Serialisation and UDI

The European Medical Device Regulation (MDR) 2017/745 published in 2017 elaborates on prior traceability regulations and introduces UDI for medical devices, which you should apply as of May 5th, 2020. UDI stands for ‘Unique Device Identification’ and consists of a device identifier (for manufacturer and model) and a product identifier (for packaging unit, batch, production date or expiration date). So, as it is prescribed now, ‘unique’ does not imply traceability of the smallest saleable unit.2

When reviewing Serialisation regulations for medicines, you will find that the identifier prescribed should be unique for every saleable unit, enabling traceability throughout the entire sequence from manufacturer to the last part of the supply chain, in particular cases even up to the individual patient. The Delegated Regulation (EU) 2016/161 published in 2016 introduces two safety features - a unique identifier (two-dimensional barcode) and an anti-tampering device - to be placed on the packaging of medicinal products as of February 9th, 2019. Although this level of identification for medicines is not yet required for medical devices, it is expected that future ‘Implementing Acts’ for the new MDR will include traceability of the smallest saleable unit, up to the patient as well.

Getting started

So, what now? Start orientating and ask yourself questions like: What is your organisation’s situation at this moment? What is your knowledge of the legal requirements and of the efficiency opportunities? What should be your next step? What do you need for that? How much time will it take? 

It’s well-advised to raise your knowledge level, provide a clear overview of your situation, do a gap analysis and provide solutions, explore different options, share best practices with others in the field, and start drafting an action plan. If you are uncertain about some aspects, don’t hesitate to contact us, we will be happy to talk to you about it.

Blog by: Louis Habets - Sr. Consultant & Trainer at Xendo

 


Footnote 1

If the European Medical Device Database Eudamed not fully functional is on May 26 2020, numerous requirements listed in the MDR and relating to where any information needs to be stored in Eudamed, will apply six months from when the Commission has published a notice declaring that Eudamed has achieved full functionality. While waiting for Eudamed to become fully functional, the corresponding provision regarding the exchange of information in the MDD and AIMDD will continue to apply. This regards particularly Vigilance Reporting, Clinical Investigations, the Registration of Devices and Economic Operators, as well as Certificate Notifications.

Footnote 2

When will UDI carriers really need to be placed on the label of devices and all higher levels of packaging as described in Article 123,3f, depends on the Risk Level of the product:

  • May 26, 2021 for Implantable and Class III devices;
  • May 26, 2023 for Class IIa and IIb devices;
  • May 26, 2025 for Class I devices.
  • How soon the UDI carrier need to be placed on re-usable devices is determined in Article 123,3g as:
  • May 26, 2023 for re-use Implantable and Class III devices;
  • May 26, 2025 for Class IIa and IIb re-usable devices;
  • May 26, 2027 for Class I re-usable devices.

24-11-2017
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#Slide Deck: Changes in the Medical Device Legislation; the day after.

Feel free to download the slide deck of one of our recent talks on the new Medical Device Regulation which was presented by Jan Bart Hak at the autumn meeting of the Pharmacovigilance  Platform Netherlands on November 21st, 2017.


The European Medical Device Regulation 2017/745 (MDR) is published on May 5, 2017, in order to replace the current Medical Device Directive 93/42; it will apply 3 years after this date. Requirements related to the technical file and procedures will be significantly reinforced, without the possibility of grandfathering.

These new requirements will affect the entire medical device (MD) industry with products in the EU. This implies that companies with products on the market within the European Union will need to come up with a transition plan to comply with these new rules and they have until May 25th, 2020 to do so.

A short calculation tells us that the countdown is at two and a half years at this point. As an example, in case the clinical evidence needs to be updated, one must start now. Clinical evidence can be collected in a clinical investigation or via post-marketing surveillance, which includes vigilance and post-marketing clinical follow-up studies. If a medical device company does not start now, it can be too late risking the CE mark and so market access.

Click here for the PDf of the full slide deck.

21-11-2017
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#MDR: Why you should start now or lose money!

Although the new Medical Device Regulation (MDR) is now officially effective (in co-existence with the Medical Device Directive, MDD) we’ve noticed that some companies are well on their way with the transition (mostly EU companies) but there seems to be only a small percentage of US companies that has actually started to transition from MDD to the MDR. Especially for Regulatory Affairs (RA) managers this might be frustrating because they are well aware that from short-term perspective sticking your head in the sand, in the long run, might cost you serious money. Here’s why.


MDD TO MDR


For those who haven’t yet had the time to investigate what (mandatory) changes the future holds in the Medical Device field, we can summarize it as follows: requirements regarding your product are increasing and becoming stricter. Examples are requirements regarding, risk classification, clinical evidence, Economic Operators, and Post-Marketing Surveillance. All currently certified Medical Devices (MDs) must be re-certified in accordance with these new requirements.
First of all, companies are well-advised to perform a GAP-analysis to see how they want to proceed with their product. Three likely outcomes could be:

  1. You find no go GAPs which means ‘no worries’.
  2. Major GAPs meaning there’s a lot of work and you should start rather sooner than later.
  3. So many GAPs that you might consider discontinuing your product and withdraw it.


This implies that companies with products on the market within the European Union who find themselves in the second category will need to come up with a transition plan to be compliant with these new rules and they have until May 25th, 2020 to do so. A short calculation tells us that the countdown is at two and a half years at this point.


To assist RA managers eager to start a possible transition we’ve lined up some situations that might motivate all their colleagues to set things in motion. We suggest exploring the three most likely options that could be considered.


1. WHAT IF I DON’T?


Definitely a bad idea. The new MDR does not allow for grandfathering meaning that products that are currently on the market will not automatically be approved to stay on the market. So, if you choose not to transition to the MDR your product will no longer be allowed on the European market and consequently, you will lose income in other countries where turnover is dependent on a valid CE-mark.


2. I’LL DO IT LATER


Tempting, but not a good idea either. To explain this, let’s have a look at the math. To be compliant with the new MDR there are activities that have certain throughput times.
For example, let us assume that your clinical evaluation gap analysis shows that you need to upgrade your clinical data with data from a Post-Marketing Clinical Follow-up study (PMCF). If we pivot these numbers against the time left until you lose your CE-mark, we come to the following:

Activities that would have to be performed against the time it would take and the time that is left in months.

All these activities alone leave you with ‘0‘ months left until your CE mark (read: market approval) expires if you aren’t compliant with the new requirements. So actually, we can say that every moment that companies are delaying the transition to the MDR they will be facing a loss of revenue from the marketed product.


3. START NOW


Yes, we agree. This does not mean that you will be overwhelmed by additional work that can’t be handled.
For instance, your strategy on extending clinical data can be considered via Post Marketing Surveillance while still under the MDD using a PMCF study to gather this data. Under the new MDR, this collection of clinical data without a CE-mark will be considered a clinical investigation, which is subject to far stricter requirements. In that case, you’ll have to set up, for instance, a new randomized controlled clinical study with a 100 patients, a 6-month patient follow-up, and at 10 different sites which is a very costly process with patient insurance, submittal to the Competent Authorities and longer timelines than a PMCF. And also for other issues, a pragmatic approach can often be chosen so that your product’s certification remains valid and continuity of sales is not hampered by regulatory issues.

ARGUMENTS & BUY-IN


We can assure you that securing buy-in from the decision makers and different stakeholders in your company is essential in situations like these. So to pave the way we’ve lined up some arguments to use in persuading that you need to start today.
Since it all usually comes down to commercial considerations, this is likely to be your strongest argument. Here are some examples to paraphrase the money issue:

  • Loss of revenue in all countries where turnover depends on a valid CE-mark
  • Correct expected projections beyond 2020
  • Losing business will eventually result in a loss of qualified staff
  • Increased investments will be required to make up to regain lost market share
  • Investors are very aware of the MDR and usually require a transition plan
  • The company’s reputation is at stake

TRANSITIONING


The implementation of the MDR or the transition, if you will, is most likely an extensive project. And this actual transition is something we’ll get back to in another blog. To put it shortly, all companies are strongly advised to come up with a comprehensive transition plan including:

  • Relevant differences
  • Risk Class Determination
  • Conformity Assessment Procedure
  • Top Management Awareness and Commitment
  • Implementation Plan
  • Assessment Partner
  • Product Documentation
  • Quality Management System
  • Post Market Activities and Reporting

In conclusion, although the deadline of May 2020 seems far away, it really is false security. To ensure continuous compliance of medical device products to the new legislation, i.e. the MDR, a swift start and a solid plan are necessary. This will bring peace of mind to any Medical Device company because business continuity is assured.


So instead of waiting around to see what the future holds, get started and find out where you’re at. And if you’d like some more specific information don’t hesitate to leave us a message.

Blog by: Nick Veringmeier - Xendo

20-11-2017
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#EMA: Welcome to the Netherlands

Rembrandt and van Gogh, tulips, clogs and windmills, a sample of what we’re famous for. We might be small, but we’re a great country. And it’s our pleasure to welcome the European Medicines Agency to The Netherlands.

The Netherlands will prove itself to be a true home to the internationally oriented EMA community and its staff thanks to its excellent accessibility, high-quality of living, and a population consisting of over 180 nationalities.

As a fast-growing company, we are ready to support all life sciences companies during the transition of the EMA from London to Amsterdam. With over 240 efficiently cooperating consultants (including QPs, QPPVs, and Auditors) in different fields of expertise, we’re able to offer our customers a complete palette of services. Especially our familiarity with The Netherlands’ Health Authority, the MEB-CBG, will prove to be an asset for all companies that require expertise regarding their upcoming Regulatory Affairs changes that this transition will bring about.

Please contact us to find out more.