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iso 13485 - medical device qms

  1. 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...
  2. J

    Does anyone here use ISOXpress/IMSXpress QMS software?

    I have used the trial version of this software and so far everything seems straightforward and adaptable to our needs Has anyone else used this recently or in the past that could provide feedback please. We are considering purchasing it and I would like to know the pros and cons before doing so...
  3. S

    ISO 13485 scope of certification - We are a virtual manufacturer

    Our brand new ISO 13485 certificate indicates that we are certified for . We are a virtual manufacturer. On seeing the certificate, I enquired from the outgoing quality manager why the scope did not say that we are a manufacturer and distributor of medical devices. He replied that "Supply"...
  4. H

    Transferring an ISO 13485 certificate to a new CB - Do I have to start from scratch?

    If a company is registered to ISO 13485:2016 and changes registrars during the audit cycle, is the new registrar required to perform a full scale audit or do they finish the audit cycle. I could not find any information on this.
  5. 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...
  6. F

    MDR ISO 13485 for Class I sw/hw company to be class II due dates

    Hi, There has been debate about the date we can no longer sell out product in the EU and need to be MDR and ISO 13485 certified. We are currently a Hw/SW device class I self-certified. When will that certification be no longer recognized? 2020, 2022, 2024. I've see multi-dates and wanted...
  7. G

    Audit finding - Components being transferred inter-plant

    Hi All, I recently completed a course to become an internal auditor to ISO 13485. I also took part in my first audit for the medical device company I work for (I’m in training). During this audit I found components being transferred inter plant ( from one global site to another) but the SAP...
  8. M

    We still have not received our certificate due to a 'backlog' with our auditing body

    Hello everyone! Made an account here as we've run into an issue and I'm wondering if others are experiencing the same. Mid-2018 we recertified our medical device manufacturing facility to ISO 13485 under the MDSAP certification plan. We completed the audit with a few minor NC's and were...
  9. 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
  10. 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...
  11. C

    Is a First Article Inspection (FAI) Procedure required by ISO 13485?

    We were talking about FAI and a person brought up we need a SOP and point me to a website. On the site it has the following- The ISO 13485 First Article Inspection (FAI) Procedure provides instruction on conducting first article inspections and generating a first article inspection report...
  12. J

    ISO 13485 Audit Nonconformance written against 6.3 Infrastructure

    NC was written - The Requirements for Infrastructure have not been fully documented because despite the fact that there is a governing procedure, the requirements themselves have not been clearly defined and documented. The building, hvac, security, pest control - is all handled by contract...
  13. 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...
  14. 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,
  15. J

    Training documentation - ISO 13485 audit and the auditor had questions

    We recently had an ISO 13485 audit and the auditor had the questions below. Are there different ways to make sure the candidate is competent in the particular standard? How did you update to new standard? How do you know the candidate is good for internal audit for ISO: 2016 standard? Does...
  16. 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...
  17. 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?
  18. 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...
  19. Q

    How to efficiently and compliantly reference external standards/regulations

    I am looking for advice on how to efficiently and compliantly reference external standards/regulations. I work for a small medical device company and we are rapidly expanding into new markets and with that we are now governed by over 100 standards/regulations. Historically we would cite 21CFR...
  20. 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
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