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  • Human Resources Training

    The reason of my message is to ask you something about the Human Resources Procedure and Trainings. The thing is that we develop a product and then we give trainings to doctors so they can use it. So my question is: ¿where should we include this training information? Because doctors are not employees of the company, they are users of the product, my question came in while filling the Procedure for Human Resources appendx.

  • 21CFR-820 vs ISO13485 Quality management systems

    Hello, we purchased the ISO13485 kit from you guys and I have a question.. We have a QMS for our NIOSH/21CFR-820 doing some research the QMS requirements are very similar, the ISO13485 is more company operations and the NIOSH/21CFR-820 is both operations and product. Since we already have the NIOSH/21CFR-820 can we use this QMS for ISO13485?

  • Sterilization need

    I have a question concerning sterilisation and whether it is required in our specific medical device area that we aim to work in. We will be making topical application products such as cream, gels or balms for eczema, acne, scalp issues, etc. The product itself won’t be sterile, but I was wondering if there was any other sterilisation process to be implemented, like equipment, packaging, etc.

  • Certification Requirements

    Are there any specific requirements for which certification bodies we use for ISO 13485? In IATF it mentions the certification body needs to be accredited by an IAF MLA member.

  • Should we have risk management procedure including FMEA for all product lifecycle?

    We bought the toolkit MDR/ISO13485 and have the following question:

    If we are a manufacturer (specification holder) and we have contract manufacturer for all our products (so practically we outsource design and development and all manufacturing stages but we only do sales activities for products under our brand name/trademark), should we have a risk management procedure including an FMEA for all the product lifecycle? Or we only make a quality agreement with the manufacturer (OEM) which includes all the requirements and we supervise implementation?

    A note all our contract manufacturers are MDR Compliant and ISO 13485 Certified.

  • Supplier to a medical device company

    We supply components to medical device companies but actually do not make a medical device.  We are ISO 13485 because we choice to be not because we had to be.  Are we required to maintain a Medical Device File?

  • Is ISO 13485 for fertility company?

    I manage a Research and Development lab for a women’s fertility company. We develop kits and assays for genetic testing but we do not manufacture anything in our lab specifically. Would ISO 13485 be the right option for us?

  • Responsibilities of Distributors for collection of Medical Devices and incident reporting

    Responsibilities of Distributors for the collection of Medical Devices and incident reporting

  • Do medical device distributors and 3rd party logistics providers benefit from implementing ISO 13485 and MRD?

    We are a 3PL. I understand that the ISO 13485 regulations were designed specifically for Medical Device manufacturers. However, do medical device distributors and 3rd party logistics providers benefit from implementing these standards? Additionally, can 3PLs be certified under ISO 13485?

  • Implementation, Compliance software, Training

    Hello, we are a research lab and are looking at setting up a diagnostics lab to make 2 of our tests available (plus NHS are interested in using them).
    We need to get the lab ISO 15189 accredited but for the tests we perform, do we also need to be ISO13485 accredited?
    For one of the tests we supply a urine collection kit. If we are to send the kit to patients for sample collection do we need to be accredited (ISO13485)?
    The company we purchase the sample collection vessel from, are already ISO13485 accredited.
    We receive the sample from the patient and then perform analysis on it so is the extraction and instrument analysis kits regarded as medical devices?
    I'm a little confused so any help would be great
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