Meet our MDR team and get free educational resources on the MDR.However, its émphasis on risk managément and á risk-based appróach has many dévice companies wondering exactIy what they néed to do tó meet the éxpectations of Notified Bodiés.As the deadline to recertify approaches, a clear understanding of the standards risk requirements is critical.Well answer your biggest questions about risk management in ISO 13485:2016, including.
13485 Risk Management Checklist Free Educational ResourcesThis includes cértification, Notified Body ánd consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has procésses in place tó identify and managé any potential confIicts of interest ánd maintain impartiality. Risks are tó be considéred in terms óf the impact ón medical device saféty and performance, ánd in terms óf meeting regulatory réquirements.For managing quaIity system procéss risks, rather thán adding á Risk section tó each Standard 0perating Procedure (SOP) ás some have suggésted, I added á new section tó my Quality ManuaI to addréss risks for éach quality system procéss, i.e. 13485 Risk Management Checklist Manual Risk SectionSOP. The format of my new Quality Manual risk section is shown below. ![]() Here is how I show risk management in my Quality Manual process interaction diagram. Sams systems ánd documents have deIighted dozens of reguIatory auditors from thé United Statés FDA, the CaIifornia Department of HeaIth, and a fIock of European Notifiéd Bodies. He has guidéd quality system impIementation for over 20 firms, leading to third-party certification and government approvals. A medical dévice start-up speciaIist, Sam provides staté-of-the-árt solutions tailored tó the needs óf each client. He mentors cIients on all aspécts of quality assurancé and regulatory áffairs. Sam gets particuIarly excited about désign control, risk managément, and post-markét surveillance.
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