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PPAP, FMEA, QP, PSW in ISO 13485 toolkit
I work as a Quality Engineer EU MDR for *** and they have ISO 13485. Will your course and ISO 13485 Toolkit cover PPAP, FMEA, QP, PSW etc as this will be part of my job role in Supplier Quality Assurance? -
Implementation ISO 13485 on making medical materials for medical laboratories
Can we use ISO13485 in the materials industry for medical laboratories? -
Classification of reusable orthopedic instruments used to fit implants
in which class are reusable orthopedic instruments used to fit implants classified ? A drill bit or reamer which are attached to a power drill in which class would they fall? A jig used in knee surgery which is used to take knee cuts would fall in which class Retractors, Gouges ,forceps would be in which class Gamma biological indicators used to check sterility of batch after gamma irradiation would fall in which class Please give rationale for selection of each class -
KPIs
We are in propcess to finalize ISO 13485 in our company(electronic industry), at the moment we still didn't define KPI. Could you be so kind and suggest me which are tipical KPIs ? We need ideas to define KPI for our core bussines: Development_Production-Sales_marketing of electronics. ISO 13485 requires to define special KPIs just for MEDICAL PRODUCT. If you have one examopl for me or one example like excel table it will be very helpfull for me. -
Gap analysis and key performance indicators
1. How to conduct gap analysis for ISO 13485? 2. How to determine key performance indicators? -
Classification
Just a quick question. If I have equipment that generates oxygen for medical applications, and the machine only generates and fills the oxygen tanks, which are then used in hospitals, etc, is the generating equipment a medical device? If so, what would be the classification? It sounds to me a bit like equipment that is used to manufacture medicines for instance, and in my opinion it should not be classified as a medical device. Your input will be greatly appreciated. We need to urgently clear this, because my client is importing the equipment to ***, and we need to know what registrations, etc, we need to apply. It is because medical devices are regulated in ***, but we apply more or less the same requirements as the EU. -
Checklist for medical device labeling including advertising and claims
How to audit and create a checklist for medical device labeling including advertising and claims -
Is ISO 9001 mandatory for company distributing medical devices?
Is ISO 9001 mandatory for company distributing medical devices? -
Implementation questions
My company has manufactured a silicone prosthetic liner. My questions: 1. Do I need to perform mechanical tests on the liner? If so, which organization can do this? 2. How long do I need to do clinical trials on the liner? How many months and how many patients need to wear the liner as part of the clinical trials? -
Regarding intended purpose or intended use
We had a sit down with one of our regulatory consultants and went through our new Manual/IFU ( it’s a combination in one document) and when we came to the chapter about intended use, she proclaimed that since the 26 of may- and MDr is in full place. Its not called Intended use anymore and everywhere it is stated intended use must be replaced with intended purpose instead- is this really the case? Then a lot of the documentation from Advisera that we purchased in December is outdated? Can you confirm or deny this?