When setting up or monitoring a quality management system for medical devices, Metecon is your partner for preparing for audits and inspections, helps with the adaptation to modified requirements, checks manufacturing processes, and much more.Test our skills – we look forward to your project!
Here's what you should know for your QM:
There are a number of programs and initiatives around the world that have made it their mission to harmonize the various QMS requirements. The Medical Device Single Audit Program (MDSAP), for example, is the effort of a working group of the International Medical Device Regulators Forum (IMDRF) (formerly GHTF - Global Harmonization Task Force) with the goal of harmonizing QMS requirements for manufacturers of IVD/medical devices. The following MDSAP countries are participating: Japan, Canada, Australia, USA and Brazil.The advantages through mergers like the MDSAP (and many more) are obvious for you as a manufacturer: The goal of only one audit for recognition in several countries reduces the associated workload in the long run. Our team of experienced QM and IVD experts will help you find and implement the best options for your target markets.Do you have questions about your QMS, are you wondering which mergers are right for you? We will be happy to find out together with you.
Arrange a meeting now - we look forward to working on a project together!
Arrange a meeting now - we look forward to working on a project together!
The Future of FDA regulation for quality management system: QMSR
The QMSR (Quality Management System Regulation) replaces the QSR (Quality System Regulation) and that means: aligning the QSR with ISO 13485.What you should do now to be prepared for the regulation, which will be effective on February 2, 2026?We can help answer your questions as well as support you with implementation.
Dunja Schildge-Reichmann
Head of Regulatory Affairs & Quality Management
dunja.schildge-reichmann@metecon.de
1. What is it all about?
In December 2018, the US Food and Drug Administration (FDA) announced that it would be adapting its quality management requirements for medical devices, the Quality System Regulation (QSR), to the international standard ISO 13485:2016.On February 2, 2024, the FDA published the final revision of the QSR (21 CFR Part 820) and 21 CFR Part 4 (Combination products) in the form of Final Rule 89 FR 7496 in the Federal Register, with an effective date of February 2, 2026.Learn more here about what QMSR will mean for you.We are happy to support you in the transition!
2. What changes significantly?
Risk management plays a significantly larger role in the upcoming final version of the QMSR; in the past, the QSR has only referenced risk management in the context of development validation.While the FDA emphasizes risk management, both pre-market and post-market, it cannot require companies to implement the risk management standards of ISO 14971. With the harmonization of ISO 13485, this will change as there is a direct reference to ISO 14971!We are ready to help you out!
3. Is there any advantage if I already comply with the requirements of ISO 13485?
Yes! Companies that have already established a quality management system in accordance with ISO 13485 will have a head start in the transition from QSR to QMSR.You have already made a great step if you already meet all the requirements today. What you will still face are the additional (new) requirements for the U.S. market.Our tip: Create a matrix to test your system against the final version of the QMSR.Are you ready to achieve your full potential? We're here to help you.
4. What should I do if I do not have a QMS according to ISO 13485?
You have two options:
This MDSAP, developed by the International Medical Device Regulators Forum (IMDRF), will enable companies to be audited by an accredited third party in a single audit to meet the quality regulations of the U.S., Canada, Brazil, Japan, and Australia!It's our pleasure to support you in this project!
- Adapt your quality management system to meet the requirements of ISO 13485, or
- Register for the Medical Device Single Audit Program (MDSAP).
This MDSAP, developed by the International Medical Device Regulators Forum (IMDRF), will enable companies to be audited by an accredited third party in a single audit to meet the quality regulations of the U.S., Canada, Brazil, Japan, and Australia!It's our pleasure to support you in this project!
5. What are the benefits of the MDSAP?
The foundational element of the audit checklist for an MDSAP is ISO 13485, so even if you have not previously implemented ISO 13485 requirements, this will give you the mechanism to replace any routine FDA inspections by a Notified Body.This gives you two advantages at the same time:
We will be happy to provide further information!
- Implementation of an MDSAP audit by a Notified Body and not through the FDA.
- Effective implementation of the ISO 13485 requirements, including the QMSR regulations.
We will be happy to provide further information!
Our services in detail
- Developing, managing, and maintaining quality management systems and quality management manuals including operating procedures and work instructions,
- Analyzing and advancing quality scores relating to customers, suppliers, and production as well as preparing relevant reporting,
- Introducing and implementing quality management (QM) tools,
- Training and workshops on skills focusing on:
- Quality regulations,
- Statistical methodologies,
- Frame contracts/quality agreements,
- Complaint handling/CAPA (corrective action - preventive action),
- Medical device vigilance/recall,
- Suppliers for medical device manufacturers:
- Supplier selection,
- Supplier audits,
- Supplier assessment.
Fit for today, fit for the future!
Our workshops give you the competence you need and help you master your current challenges. Let us find out together what you really need. Our expert workshops are always sustainable and individually tailored.Get more information now