Every marketed product has risk. The stakes are rarely higher, though, than in the medical device industry.
A comprehensive risk management analysis – around ISO 14971 guidelines – can mark the difference between your product’s successful arrival on the market, or needing to spend another near-eternity in development.
Make sure you get your plan right. With more than three decades of medical device consulting experience, SpectraMedEx knows ISO 14971 like a family member. We’ll get you acquainted by structuring the required logical arguments the right way: hazard analysis, failure mode, effects analysis, fault tree analysis, hazard identification, and more.
Our approach uses proven templates, risk-benefit analysis, full explanation of terminology, and reviews of assurance cases and safety cases. Vagueness is barred and no stone is left unturned.
True, your business is continually evolving, which poses ongoing risks. Product designs change. Complaints are filed. Non-conforming products emerge. We’ll teach your team how to stay in FDA compliance, or pass an ISO audit. Should either entity show up unexpectedly, with assistance from SpectraMedEx, you will be prepared.
Some risks are important and others are less impactful. All require accountability. SpectraMedEx figures out which risks are which – and designs your risk management strategy to reflect the real stakes involved.