EU MDR 2017/745 "Safety & Performance Requirements" vs. 93/42/EEC MDD "Essential Requirements"

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State of the Art

Sam Lazzara Resume LinkedIn Profile   Documents Services Schedule Call   +1 510 397 9739 sam@lazzara.net ISO 13485 requires the control of "documents of external origin" such as regulations, standards and guidelines that impact the quality management system (QMS). Changes to these external documents must be identified and appropriate actions taken to maintain "state of the art" medical devices. For example, Essential Requirement 2 of the European Medical Device Directive states: "The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art." Keeping up to date with evolving international regulations, standards and guidelines is always a challenge. It is one thing to become aware of revised documents; it is something else to determine the impact of the revisions on your QMS and devices. Regulations, Standards, Guidan
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ISO 13485:2016 Quality System Process Risk Management

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I SO 13485:2016 has a broader view of risk management than in the past. Risks are to be considered in terms of the impact on medical device safety and performance, and in terms of meeting regulatory requirements. For managing quality system process risks, rather than adding a Risk section to each Standard Operating Procedure (SOP) as some have suggested, I added a new section to my Quality Manual to address risks for each quality system process, i.e. each SOP. The front end of my new Quality Manual risk section is shown below.  A row is included in the table for each SOP. Since my Quality Manual already lists the SOPs, this makes sense to me. And by having all of the risk assessment and control information in this single document, it seems easier to manage than sprinkling risk assessment/control info into each SOP.  Sam Lazzara Resume LinkedIn Profile Documents Services
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Put ISO 13485:2016 in your rear-view mirror

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Enough is enough! You heard that ISO 13485:2016 was published in March 2016, and maybe you purchased the standard. But with everything else going on in your life, you have not had the time to figure out how or when to deal with it. Well....now is the time to get the 13485 monkey off your back. Starting from scratch? I have cracked the 13485:2016 nut, and can provide a full deck of documents tailored to your needs. Looking to update your current system? I have developed some tools for gap analysis so you can self-diagnose your needs. Need training? I can provide a "live" training session via webinar or in your office if you are in the SF Bay area. Want to discuss? Please directly book a call time by  clicking here . Lazzara 13485:2016 Quality System Document and Services Description Sam Lazzara About Me     sam@lazzara.net      +1 510 397 9739      Directly Book Call Time
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