Team Lead, Quality and Regulatory Affairs
Labquality provides medical device manufacturers help in setting up and implementing a risk management system and preparing risk management documentation for their medical products.
Medical device risk management is most conveniently performed following ISO 14971, a standard to be harmonized with Regulations 2017/745 (MDR) and 2017/746 (IVDR).
✔ Planning the risk management process together with the manufacturer
✔ Writing the risk management process description in accordance with applicable standards and regulations
✔ Helping the manufacturer to implement and maintain the risk management process
✔ Preparing risk management plans and reports
✔ Helping the manufacturer with risk analysis covering all needed aspects (e.g., manufacturing processes, quality processes, design, usability, software, cybersecurity)
✔ Helping the manufacturer with benefit-risk determination
✔ Helping the manufacturer in answering the risk management related questions raised by notified bodies and authorities
✔ Offering customized and open training for medical device risk management
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