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ISO 13485 is a global term for quality assurance guidance and is curated precisely for the medical device industry. This standard is known for highlighting the best policies and guidelines for maintaining regulatory compliance in this industry. Check out this blog post to help maintain compliance.#iso #iso13485 #qualityassurance #medicaldevice #asutralia  https://lnkd.in/g4-kgtDR

ISO 13485: Quality Management System for Medical Device Manufacturing hashtag #ISO13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. hashtag What is #ISO13485 Quality Management System: #ISO13485 and #ISO9001 for medical devices: There are significant similarities between the two standards, including: #QMS

https://lnkd.in/gqvCkhny For those medical device companies that do not currently follow the ISO 13485:2016 requirements, the transition to the QMSR could require a significant effort to identify any gaps in their current quality management system and make the changes by Feb. 2, 2026. ISO 13485:2016 Element 5 Management Responsibility may not involve major QMS changes, however, there are some additional requirements over the current QSR and I summarize those here as a reference. If you are looking for a comprehensive 41-page QMSR Gap Analysis Checklist, go to our website: https://lnkd.in/gSbjhEnN Looking for assistance with the QMSR transition contact us by "Book an appointment" and we can start a discussion. #iso13485 #fdaqmsr #qualitymanagement #gapanalysis

https://lnkd.in/gSgcCuEJ (13485 Store) Some USA based medical device companies that are currently not meeting ISO 13485:2016 QMS requirements may need to make some significant changes to their supplier approval and management procedures in order to meet the QMSR, and by reference the ISO 13485:2016 requirements. The time to start understanding the detailed ISO 13485:2016 Standard is now. This should be followed by a QMSR Gap Analysis and Implementation Planning process. We have available at our store, link above, a comprehensive QMSR Gap Analysis Checklist. Also a Quality Manual Bundle and Procedure templates, including those for Purchasing and Supplier Approval, as well as others that can potentially fill any QMS gaps. If your a medical device company looking for assistance with any part of the transition to the QMSR, contact us and we can start a discussion. #iso13485 #fdaqmsr #medicaldevices #qualitymanagement #gapanalysis

https://lnkd.in/gqvCkhny For those medical device companies that do not currently follow the ISO 13485:2016 requirements, the transition to the QMSR could require a significant effort to identify any gaps in their current quality management system and make the changes by Feb. 2, 2026. ISO 13485:2016 Element 6 Resource Management may involve some significant changes for some companies and I summarize those here as a reference. If you are looking for a comprehensive 41-page QMSR Gap Analysis Checklist, go to our website: https://lnkd.in/gSbjhEnN Looking for assistance with the QMSR transition contact us by "Book an appointment" and we can start a discussion. #iso13485 #fdaqmsr #qualitymanagement #gapanalysis

https://lnkd.in/gSbjhEnN - QMSR Gap Analysis Checklist https://lnkd.in/gmXncujk - Supplier Approval SOP Template & Forms Medical device companies that do not currently follow ISO 13485:2016 requirements could have many significant quality management system gaps that must be addressed to transition to the QMSR. Supplier Approval based on risk could be one of those significant changes that will need to be implemented. If you're interested in obtaining our procedure template for Supplier Approval you can go to the link above. Our 41-page QMSR Gap Analysis Checklist can be a great tool to help identify all of the gaps in your QMS and develop a transition plan. If you are looking for some help with your QMSR transition, please go ahead and contact me through email or LinkedIn message and we can start a discussion. #fdaqmsr #iso13485 #qmsrgapanalysis #qualitymanagement #qmsrtransitionhelp #supplierapprovalprocedure

https://lnkd.in/gSbjhEnN The clock is ticking, so start now your quality system changes to meet the FDA QMSR requirements with completing a detailed gap analysis checklist. Go to the link above for a comprehensive 41 page checklist that compares the current QSR to the ISO 13485:2016 and QMSR requirements. I also recommend that medical device companies also consider planning to obtain ISO 13485:2016 Certification. This post provides a summary of the benefits of certification and the process steps involved. Certification is not a requirement from the FDA, however after going through the effort involved in making the changes to your QMS to meet the ISO 13485:2016 requirements, why not obtain certification? Medical device quality professionals, I would love to hear your opinion on this in the comments area. #iso13485 #medicaldevices #qualitymanagement #fdaqmsr

ISO 13485: The Quality Management Standard for Medical Devices #ISO13485 #QMS #medicaldevices #guidelines #pharmaguidelines #ISO https://lnkd.in/gkiG_ATh