ISO 13485 & QMSR

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ISO 13485 is indispensable in the medical device business. BioReg can build a complete ISO 13485-compliant Quality Management System (QMS) for your company or only review your current QMS and SOPs. We can also prepare you for the ISO 13485 audit. In addition to ISO 13485, our team advises on QMSR, MDSAP, and FDA 21 CFR 820.

The requirements of ISO 13485 apply to medical device companies regardless of the size and type of products they produce.
ISO 13485 specifies requirements for a quality management system where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The organizations can be involved in one or more life-cycle stages, including design and development, production, storage and distribution, installation or servicing of a medical device, and design and development or provision of associated activities (e.g., technical support).
Whether you want to operate internationally or expand locally, ISO 13485 certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. In addition, companies with this certification communicate a commitment to quality to both customers and regulators.

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FDA Quality Management System Regulation (QMSR)

On January 31, 2024, the FDA issued a final rule amending the device’s current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many regulatory authorities worldwide – ISO 13485:2016. You can see the final rule here.

As per ISO 13485 (4.2.3), medical device manufacturers will now need to contain or reference the procedures and specifications for the entire life cycle of the manufactured product – in the Medical Device File (MDF). The final design output from the design phase, which was previously maintained or referenced in the design and development file, will now form the basis of the MDF.

Timelines for QMSR  Implementation

Medical device manufacturers who already market their products in the U.S. or intend to do so will have two years to upgrade their quality system to include ISO 13485:2016 requirements. FDA will begin to enforce the QMSR requirements at the beginning of February 2026. Our advice is – start now!

Frequently Asked Questions

Question: A medical device manufacturer service provider wrote that a US-based customer (medical device manufacturer that markets medical devices in the EU) was audited by a Notified Body (NB). NB told them their ISO 13485:2016 certificate was invalid as it had not been issued by an NB. They explain that non-NB parties are unaware of MDR quality issues and, therefore, they don’t accept such certificates. Is such a Notified Body approach correct?

Answer: No, such NB approach is not correct. We received similar complaints from our clients. NBs could be concerned about everything. However, such concern doesn’t give them the right to “invalidate” the ISO 13485 certificate issued by the non-NB accreditation body. If NB suspects that the non-NB party that issued the ISO 13485 certificate is unaware of MDR-related quality aspects, they should check them during their annual audit. After all, the manufacturer is expected to meet quality MDR expectations, and it can summarize them, e.g., in the Strategy for regulatory compliance procedure, which may include the control of your service providers.

BioReg Services

Don’t hesitate to contact us for assistance with ISO 13485 and QMSR transition.