Can YOU help? --> Unanswered questions <-- (Other than Marcelo's Informational posts)

iso 13485:2016

  1. M

    Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3

    Good day all. I posted this as a piggyback comment in a separate thread, but figured it might get more visibility as a standalone thread, so here we go: I work for a contract medical device component manufacturer. During a recent ISO 13485:2016 surveillance audit, we got dinged for not having...
  2. I

    Medical device Validation/Verification template

    Dear All, Does anybody have a template or example for verification and validation activities and associated testing plan for 13485 (no software)? The device is a basic stainless steel instrument. We lack experience in this area and to see an example of how this should be done would be...
  3. M

    Quality Manual for 2nd site

    Our company is expanding some of our production to another site. We'll be using all the same procedures etc since it's production we are currently doing now. Was looking for advice/tips about the quality manual. I don't think we need a separate one or do we or do I just add the address to the...
  4. C

    Internal Audit - Process Clause Matrix / Audit Checklist

    Hi All, I have a question regarding the internal audit process. Please see below background about the company I work for: Our site is certified to ISO 13485:2016 and 21 CFR 820. We have an extensive audit checklist (13485 and 21 CFR 820) which is pretty much in the form of turning every clause...
  5. Marcelo Antunes

    Informational Questionário – Análise crítica sistemática – ISO 13485:2016 (Portuguese-only)

    A ISO 13485:2016 se encontra em processo de análise crítica sistemática (para maiores informações sobre o processo, favor acessar o guia Guidance on the Systematic Review process in ISO) . Para coletar percepções dos usuários da ISO 13485:2016 no Brasil para permitir a criação dos comentários e...
  6. Ed Panek

    Small Medical Device company - Bring production in-house

    As the title says, we are 13485 and Class II FDA cleared and CE. We have used contract manufacturing and our ISO scope does not include manufacturing or service. We want to add production. I have created a high-level flow chart from customer order to delivery and invoice of the connecting...
  7. I

    Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges?

    Apparently there are some possible changes on the horizon which would make hand-held medical devices class 2 instead of class 3 which would allow FDA audits of suppliers for the parts. So if I have to move my company from ISO-9001:2015 compliance to ISO-13485 compliance what are the major...
  8. Marcelo Antunes

    Informational ISO 13485:2016 under systematic review

    As can be seen in the ISO 13485:2016 page on the ISO website – the standard is under systematic review. Systematic review is required for each standard and deliverable from ISO. It helps in keeping the documents up-to-date. Usually, the systematic review is performed every 5 years, but due to...
  9. D

    Software Validation - Contract manufacturer of Components (PCBA's)

    We are a contract manufacturer of components (PCBA's). We do not manufacture finished medical devices. We are not registered with the FDA. We receive prints from our customers that detail the product and its requirements they are purchasing from us. We take design and development as an...
  10. S

    Post Market Surveillance and Annual Product Review in ISO 13485

    ISO 13485:2016 states the following: 8.5.1 General The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system as well as medical device safety and performance through the use...
  11. C

    Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016

    Hello Everyone, Our company is the legal manufacturer for some reagent kits and related instruments for IVD. We will be having the re certification for ISO 13485:2016, as we only had surveillance audit after the transition and we are not sure if we have sufficient updates on the documentation...
  12. Ed Panek

    User Feedback both negative and positive and acting upon those metrics

    A requirement for FDA and 13485 is user feedback both negative and positive and acting upon those metrics. Our product once was sold primarily in retail so we used feedback from Amazon and Walgreens etc from the web and social media Our new product is consumable in the hospital. My fear...
  13. E

    MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP

    Hi there! We're a small Canadian company that manufactures medical devices for the Canadian and US markets and have a MDSAP audit scheduled for later this year. From what I've gathered online, the MDSAP program framework mainly consists of ISO 13485:2016 and GMP, in our case FDA 21 CFR Part...
  14. J

    ISO 13485 8.4 Analysis of Data - Procedure example

    Does anyone have a good procedure example of 8.4 Analysis of Data or maybe a Procedure that has that clause tied into it with others. I searched couldn't find any. Thanks
  15. B

    ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance

    I would appreciate some insights regarding the new EU MDR's requirement for a harmonized standard for the quality management system. We currently have an approved product in the EU market and our AR had told us that ISO 9001 compliance was sufficient in regards to addressing the quality system...
  16. T

    ISO 13485:2016 - Processes exempt from process validation

    ISO 13485:2016 defines criteria for processes which need to be validated. I want to ask that the processes which do not need to be validated, is there any requirement for equipment qualification for those processes, or IQ, OQ, PQ requirements? If yes, how to go about it as complete validation is...
  17. J

    ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt?

    Exempt from these 3 ISO 13485 clauses? 7.5.2 - My company is a distributer of a non-sterile product and have no required cleaning instructions besides a recommendation for the user. 6.4.2 - Returned product is received but any product that has been returned from the hospital is decontaminated...
  18. C

    Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed?

    In Medical device mfg (class 2 13485:2016) is a deviation acceptable? If not or is, where is it stated in the regulations? Thank you,
  19. J

    EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances

    Hello Everyone, I have a questions - We recently had a audit for ISO recertification and product registration. We had 10 minor conformities and the notified bodies informed us that we have demonstrated the capabilities needed to apply for Annex II conformity assessment route. So this will...
Top Bottom