ISO 13485 & EU MDR - Expert Advice Community

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  • 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?
  • Declaration of Conformity according to MDR

    Is there a template to follow for the Declaration of Conformity according to MDR?

  • Questions about the implementation

    1. When the ISO needs to be finished / audited? (e.g. when company is founded, when first device is sold or…? – E.g. Section 7: Product Realization is with planning etc. is running right now while the company is not yet founded.

    2. Is English as language enough or is the country language additionally necessary?

    3. Is the IVD guideline 98/79/EG (IVDD) and/or German “In-vitro-Diagnostika-Verordnung (IVDR)“ additionally necessary and incorporated in your toolkit? If not, can you recommend a toolkit for this? Background: In simple terms, the product is a special microscope with which a view of a tissue sample can be created and viewed. The interpretation of this image is done by a pathologist (unlike, for example, a blood pressure monitor, where the device interprets something). Staining of the tissue sample is done outside the device using standard procedures/products from appropriate manufacturers (e.g. H&E staining).

  • ISO 13485 implementation

    Thank you very much for letting me put my question. My main concern right now is, is it possible to prepare all the required documents without letting expansive consultant to do it for us? What would be the challenging part while preparing document by company staff? If we use Advisera Templates and experts advice for preparing our documents, how much time will it take to get thing done for class IIa medical device?

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