medical-devices

Design, manufacture and marketing of Medical Devices represents a wide and diversified type of activity within the Life Sciences industry and, as a result, is strongly subject to very strict levels of compliance with current and changing regulatory principles.

TDV will undoubtedly contribute to successfully achieve the targets of your projects, not only ensuring the highest levels of compliance throughout the entire product’s life cycle, but also that their use will be carried out with maximum safety and performance requirements guarantees and with absence of risks for the patient or the end user of the medical device.

From TDV we offer different assistance services to our clients and collaborators, all of them focused and aligned to string along with them in the rigorous and effective fulfillment of all the applicable regulatory requirements for the design, development, production, marketing and market surveillance of their Medical Devices in the market. TDV will provide services in the following areas:

  • Consultancy services in:
    • Medical Device classification (according to new regulations (EU) 2017/745 and (EU) 2017/746)
    • General Safety and Performance Requirements compliance and fulfillment according to the EU Regulation
    • CE Marking process in Europe
    • Medical Devices marketing process in USA
    • CE Marking process and Medical Devices marketing process in Europe
  • Management Systems design and implementation:
    • Quality systems based on ISO13485 and 21CFR Part 820
    • Quality Risk systems based on ISO14971
    • Design and development of software as a Medical Device according to ISO 62304
    • Postmarket Surveillance systems
  • Issuance of technical and regulatory documentation:
    • Technical File
    • Related documentation for 510 (k) and PMA
  • Qualification and Validation services
    • Medical Devices manufacturing processes
    • Manufacturing equipment and facilities
    • Computerized Systems as a part of the Medical Device
    • Standalone computerized systems and mobile applications.
  • Audit and inspection services
    •  Audit and working plan for new European regulations compliance
    • Quality System Self-Inspections
    • Manufacturer and Supplier audits
    • FDA mock inspections
    • Notified Body audit preparation

Núria de la Fuente
ndelafuente@tdvct.com