iso 13485:2016

  1. J

    ISO 13485 - 7.5.2 cleanliness , 6.4.2 val 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...
  2. 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,
  3. 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...
  4. 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?
  5. 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)?
  6. 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...
  7. 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...
  8. 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...
  9. 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
  10. 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...
  11. S

    Saving QMS documents in cloud drive - Compliance with ISO 13485

    Hi everyone, If a company keeps QMS documents in a cloud drive (e.g. Microsoft OneDrive), is this out of compliance with 13485? If so, what sort of work can they do to improve this process? Are there small startups that keep their documents all in a cloud drive? ( OneDrive, GoogleDrive) as...
  12. kiwi.kczt

    Is Mold qualification / process validation always required?

    Hello, We are outsourcing manufacturing of a injection molded component of a Class IIa medical device to a factory. ISO13485:2016 clause 7.5.6. states: "The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by...
  13. J

    ISO 13485 Recertification audit extension

    Hello- I'm wondering if anyone has had to get an extension for a recertification audit, what the process is, how long the extension is good for? We previously added 13485:2016 to our scope during a surveillance audit. We had a scheduled audit for recertification to 13485:2016 and MDSAP. The...
  14. B

    Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820

    I am taking over the QA/RA Management Representative role for my company and looking for some classes and/or online training for FDA and ISO 13485. We have a couple Class 2 medical devices(Dental Imaging Software & IntraOral X-Ray Sensors) and two Class 1 medical devices (IntraOral Camera &...
  15. S

    Critical supplier - Obligated to have an ISO-certified QMS?

    Hi everyone, As a critical supplier (contract manufacturer), are they obligated to have an ISO-certified QMS? Or any kind of QMS? Thanks!
  16. T

    RISK: Selling Diagnostic Devices on Amazon

    HELP/ADVICE PLEASE I have once again been asked by our CEO about selling our trademarked Class I and Class II biologic culture/diagnostic devices on Amazon. Our marketing director is convinced that we need to be in this arena... The idea of using Amazon makes me VERY nervous as some of our...
  17. S

    PPT for ISO13485:2016 Employee Training (Request)

    Dear All., It is a request that kindly share PPT for ISO13485:2016 for training purpose. Thanks in advance:thanx:
  18. S

    Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness

    I was recently given a noncompliance against ISO 13485: 2016, clause 6.2 Human resources because of the NOTE " The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided." I am a contract converter...
  19. C

    Defining Approvals Required for Design Control Documents

    Associates, I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types. I know there's some flexibility in who the organization identifies as required signatories on documents per...
  20. M

    Multiple missed POs grounds for SCAR?

    Hypothetically speaking, if a supplier repeatedly doesn't fulfill a PO, either wholly or partly, is that grounds for a SCAR? The product that DOES ship is good (i.e., meets all product specifications) so it's not a product issue, and from what I've found, ISO 13485:2016 doesn't speak to process...
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