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iso 13485:2016

  1. 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...
  2. 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...
  3. 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...
  4. 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...
  5. 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...
  6. 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...
  7. 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
  8. 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...
  9. 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...
  10. 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...
  11. 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,
  12. 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...
  13. P

    Notified body located in an other country than manufacturing company

    Hi, can anybody tell, if a notified Body locating not in the country of the manufacturer has to verify regulations that are just valid for the manufacturer because it is local law?
  14. E

    Template of a Management Review Agenda or Report in compliance with ISO 13485:2016

    Management Review Agenda or Report to ISO 13485 : 2016 ( not to ISO 9001:2015)?
  15. M

    Startup Company - Implementation of ISO 13485

    I have taken a look at the other threads which are very useful but i don't feel like anyone has explicitly asked and answered this question. We are building a pure software medical device and need to implement iso 13485. Is it feasible to implement this standard on our own without prior...
  16. M

    Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body

    Greetings all, I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't...
  17. E

    Sample size for design verification of variable in single use device

    Hi All, long time reader, first time poster. I am a mech. engineer, frequently involved in "bench testing"of medical devices. I have trauled through the forums many times over the last few years on sample size selection and never really get much wiser. I've asked as many colleagues as I can in...
  18. J

    ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence

    Hello, I am trying to satisfy ISO 13485:2016 section 6.2 Human Resources and I got stuck on how to go about documenting the process for establishing competence, do I have to create an SOP or does our Training SOP cover this? Thanks, James
  19. J

    Implementing EN 62304:2006 on existing and proven medical devices

    Hello all. This is my first time here, and I am looking for some advice on this standard. The thing is our company manufactures simple medical devices (all in class IIa according to rule X of 93/42/EEC), and the devices are well-proven and widely sold here in Argentina and some other markets...
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