Helpful QMS information

For medical devices and IVDs

Why reinvent the wheel? In fact, there are some very helpful QMS information out there. Clearly, they can make your life easier. Especially when you’re a process owner or quality system responsible person.

Besides the here motioned standards you should also consider harmonised process standards here.

Medical devices – Post-market surveillance for manufacturers (ISO/TR 20416:2020)

Undoubtedly, this standard is an excellent description of the post market surveillance process. In fact, it takes the MDR and IVDR into account. Such as the post market surveillance plan and report. It also talk yout statistical methods.

What is safe and what is risky? This guide defines safety, safe, effective, and effectiveness.

Gap List

ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management

Fully interpreted and ready to use in ColabON

Intended Purpose = Intended Use

This is a absolute must have for medical devices. Because the MDR doesn’t define intended purpose well. But here it is.

Medical Devices Intended Purpose = Intended Use

MDCG 2020-6

All regulatory requirements with the topic intended purpose and intended use are identified in ColabON.

The MDR defines ‘intended purpose’, but not ‘intended use’. And this guidance document finally suggests that ‘intended use’ should be considered to have the same meaning as ‘intended purpose’.

Hence, you can follow the Definition of clause 5.2 form ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management.

In addition, we want to emphasis that the MDR device description lists all contents of the intended use separately. Hence, make sure that you don’t duplicate information.

Luckily, IVDs are better off. Because, the IVDR is very clear about the definition of intended purpose.

Clause 4.3 Competence of personnel

Most organizations struggle to describe roles in their quality management system. Therefore we find this clause very helpful. Where this clause includes competence examples of personnel.

Role

State your companies global quality roles in ColabON. Define, roles, responsibilities, authority and competence at one place.

MDSAP Documents

There is helpful QMS information on the FDA homepage: List of MDSAP documents.

Gap List

ColabON focuses on the MDSAP Audit Approach Procedure. The information in this document is very helpful, because it collects all the requirements on a quality management system for 5 major markets.

Fully interpreted and ready to use in ColabON

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations authorized and recognized by the participating Regulatory Authorities to audit under MDSAP requirements.

FDA, Medical Device Single Audit Program Frequently Asked Questions, Version 018 2022-08-22