Medical Devices

Compliance with regulatory requirements is essential in the medical device industry. Xendo can help you to get your products to the market by setting up the technical file (CE mark and/or FDA approval) and quality management system, e.g. ISO13485. We can also guide you through the review and inspection phase. Once approved we can assess your compliance level, maintain systems that will make you meeting your goals or assist where the needs are.

arrow_h1_homeScope of services Medical Devices

Specific services for the Medical devices industry are:

  • Compliance with the European Union legislation:
    - Active Implantable Medical Device Directive 90/385/EC
    - Medical Device Directive 93/42/EC, including the revision according to 2007/47/EC 
    - In Vitro Diagnostic Medical Device Directive 98/79/EC
  • Generation and updating of the EU technical file
  • CE marking / CE registration
  • Compliance with USA FDA regulations
  • Generation and updating of FDA 510(k) and PMA (Pre-Market Approval) filings
  • Implementation of specialized quality systems such as ISO 13485, Canadian CMDCAS and 21CFRpart820 Quality System Regulations
  • Risk management (ISO 14971), during design and development projects
  • Clinical evaluation and clinical trials
  • Preparation for notified body, FDA and other regulatory inspections
  • Post marketing surveillance and vigilance
  • Authorized representative for non EU manufacturers
  • Interim management
  • Project management for validation studies, stability studies, registration, product development, etc.
  • Auditing services (internal, external, suppliers)
  • Project management
  • Training
 
 
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