Medical Devices

From TDV we provide integral support during the development, production, certification, registration, commercialization and post-commercialization follow-up (or in the market) of medical devices, in-vitro diagnostic products and medical device software (MDSW) in Europe and USA.

 

We offer different services along the entire value chain of medical devices, aimed at meeting the quality objectives and regulatory requirements in each case.

From TDV we can provide consultancy and regulatory advice in the following areas, always adapting to the requirements of each client and seeking to adopt the best solution for your company:

 

Consulting and advice

 

  • Marketing process in the United States:
    • Classification of the Medical Device
    • 510(k) and PMA submission

 

  • Marketing process in Europe:

 

Design and implementation of Quality Management Systems

  • Based on ISO 13485 and 21CFR Part 820
  • Risk management based on ISO 14971
  • Design and development of Software as a Medical Device according to IEC 62304
  • Post-Market Surveillance

Approval of suppliers

  • Risk-based supplier classification
  • Supplier Risk Assessment
  • Preparation of Quality Agreements / Audit Questionnaires
  • Supplier audits

 

Qualification and Validation

  • Manufacturing Processes of Medical Device
  • Manufacturing Equipment and Facilities
  • Computer systems associated with Medical Device
  • Stand-alone Computer Systems and Mobile Applications (Medical Device Software)

Audits

  • Audit and work plan for compliance with the new European regulation
  • Internal Quality System Audits
  • FDA Audit Preparation
  • Preparation of Audits and Inspection of Notified Bodies
  • Preparation of MDSAP Audits

Training

  • ISO 13485 and 21CFR820 (Medical Devices) Quality Management Systems in the development and manufacture of Medical Devices
  • Medical Device Software (IEC 62304)

 

 

 

For more information on services for Medical Devices, please contact

Núria de la Fuente
ndelafuente@tdvct.com

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