Medical device auditing

Independent auditing support for your QMS

Let us support your next audit

Whether it’s a notified body audit, a supplier audit or an internal audit, our ISO 19011 trained auditors can prepare you, support you on the day, or take the audit off your hands entirely. Contact us to discuss what you need.

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Finding an independent medical device auditor for your QMS isn’t simple, especially with the training and certification requirements that come with it. Notified body audits add another layer of pressure: they’re often extensive, and preparing for one properly takes real audit experience. Biotop Medical’s auditors are trained to ISO 19011 and hold the certifications to support you through notified body audits, supplier audits and internal audits.

Whether you want us to run the audit for you, prepare you for it, or just review your setup beforehand, we adjust to what you need.

Our auditing services include

Notified body audits support

Notified body audits are usually the most demanding audits your QMS will face. We help you prepare in the months beforehand, walk through your documentation with you, and support you on the day itself so nothing catches you off guard.

If gaps come up during the audit, we help you draft the response and close them out within the timeline the notified body sets.

Supplier audit for medical devices

Your suppliers are part of your quality system too, and ISO 13485 expects you to keep an eye on them. We carry out supplier audits on your behalf, using a checklist built around the risks specific to your device and your supply chain.

That gives you documented evidence of supplier oversight, without having to build up in-house audit capacity just for this.

Internal audit for medical devices

ISO 13485 requires you to run internal audits on a regular basis, and the auditor has to be independent of the process being audited. That’s hard to arrange in a small team where everyone’s hands are in everything.

We take on that internal audit role for you, so the independence requirement is met and you get a genuinely fresh set of eyes on your QMS.

Services

For direct contact call
+31 (0)71 528 01 12
Questions? Contact us
info@biotopmedical.nl

Get in touch!

Curious what an audit with Biotop Medical would look like? Get in touch for a free, no-obligation conversation. We’re happy to help.

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    Why BioTop Medical?

    ISO 19011 trained auditors who know medical device QMS inside out

    Questions? Contact us

    For direct contact call
    +31 (0)71 528 01 12
    You can also email us
    info@biotopmedical.nl

    FAQ about auditing

    What is an internal audit?

    An internal audit is a periodic check of your own quality management system, carried out by someone independent of the process being audited. ISO 13485 requires you to run these audits regularly to catch issues before an external auditor does.

    What is a supplier audit?

    A supplier audit checks whether one of your suppliers, such as a component manufacturer or contract manufacturer, is working in line with the quality requirements you depend on. ISO 13485 expects you to have oversight of your critical suppliers, and a supplier audit is how you document that.

    What is a notified body audit?

    A notified body audit is carried out by the organisation that certifies your QMS and CE-marks your devices under the MDR or IVDR. It’s usually the most thorough audit your company goes through, and it determines whether your certification stays valid.

    How long does an audit take?

    That depends on the type of audit and the size of your QMS. An internal or supplier audit typically takes a day. A notified body audit can run over several days, depending on how many processes and sites are in scope.