Risk Management ISO 14971

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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