ISO 13485 & EU MDR - Expert Advice Community

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  • Replacement for Directive 93/42/EEC

    According to MDR 2017/745 - which kind of certification will replace Directive 93/42/EEC?

  • Training in the company

    I would like to check with on actual process for Training in company.What are documents required and who will be the people responsible.

     

  • Symbol MD in the label of Medical Devices Class I (no sterile)

    Hello,

     

    from today on, to be compliant with the new EU MDR, the production of Medical Devices Class I (non sterille), needs to have the MD symbol in the label?

     

    Thank you,

    Isabel Sottomayor

  • Standard for chlorine dioxide sterilization of medical devices

    What standard to I require for chlorine dioxide sterilization of medical devices?

  • Question about requirements

    We have extended our MDD and I have done a gap analysis according to CAMD Transition Sub Group
    Specifically Section III.
    But I'm now wondering are there other requirements that I'm missing?

  • Rework procedure

    Is a rework procedure needed for ISO13485?

  • Test method validation

    We have been certified recently. Nevertheless I still have some troubles with test method validation. It’s a very complex material.

    Currently, I struggle to establish whether a validation has to be conducted on some benchmark or our product. The product of ours is being developed. Currently we found optimal conditions to conduct the trial of production process. Development of the product is promising so we’ve decided to validate a crucial process. Do you have any thoughts on that matter?

  • Auditing process

    I would like to ask few questions on iso 13485 internal auditing clause 8.4. I am required to audit a process within my company, this process is Control of Non Conforming product, the audit will be remote. My question is where do I start and what do I look at when auditing this process? What kind of questions do I ask and what evidence must I look at or request?

  • Clinical Evaluation for Class A Medical Software

    Is Clinical Evaluation for Class A Medical Software mandatory during submission for certification related to ISO 13485:2016

  • MDR - difference between configurable device and device with accessories

    I am working on the documents to comply with the MDR for our products. I'm a bit confused about what applies to my case: We send a kit with a main device and some parts that can optionally be attached to the main device for certain patient groups to fulfill the intended purpose of the main device. So some patients will need the parts on the device, others not. Can we call this a configurable device or is this a device with accessories? And if this is a configurable device, when would this have been accessories? If I understand it correctly from the MDR, we need a separate Declaration of Conformity and Technical file for accessories, but not for components of a configurable device, right?

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