In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental...
November 14, 2019, Ashland, MA – MEDIcept Inc., a leading international Quality and Regulatory consulting firm focused on medical device and invitro diagnostics, and ACMP Consulting, Acton, MA have entered into an agreement to provide Clinical Research Organization...
MEDDEV 2.7.1 and what it means for clinical evaluations and reports If you are a medical device manufacturer planning to sell your devices in Europe, you’re aware by now that there have been significant changes in EU regulations recently that affect how medical...
The area of genetic testing has expanded significantly in recent years with more types of testing becoming available for both clinical and non-clinical applications. The AMA states there are more than two thousand genetic tests available to aid in the diagnosis and...
Risk Management Series – Part 4: Transferring Risks from Fault Trees to FMEAs MEDIcept is presenting this ongoing series of articles focused on the conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk...
Risk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis MEDIcept is presenting this as an ongoing series of articles focused on the conduct of risk management in the medical device industry. The intent of the series is to provide...
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“MEDIcept was effective at helping refine my thinking regarding new methods for RCR and helped prepare the new invention for commercialization. Very efficient communication and offered relevant feedback throughout the process. MEDIcept is a valuable resource for any surgeon-inventor.”
“Thank you, I am confident your assistance will go a long ways with the PV team as we prepare for the inevitable FDA audit. I now consider your organization part of the PV team and believe your collaboration will be ...
