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...
Medical Device Risk Management Series – Part 2: Prioritizing Risk Management Activities This second article in our series addresses a common risk analysis problem – prioritization. In large medical device companies, the email invitation to a Failure Mode...
Risk Management White Paper Download MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device industry.
Risk Management Series – Article 10: Human Factors Evaluation Report Forward: MEDIcept is very active in both assessing device usability and integrating the outputs of usability studies into other elements of manufacturers’ Quality Management Systems (QMS),...
Risk Management Series – Article 9: Risk Management Report Foreword MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight...
“Medicept is an outstanding quality consulting firm which never misses a beat on matching the client’s Quality needs with the daily, regulating and mandated FDA and ISO requirements.”
“MEDIcept has been easy for all to work with, they know a lot about out company and everyone actually enjoyed working with them. Their consultant, Fides Maldonado conducts herself as a professional, she added value to many projects and communicates ...
“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 ...
