QMS - Quality Management System for Medical Devices and IVDs
A strong QMS is the foundation of compliance and product success.
We help you build and maintain a system that meets regulatory standards while supporting efficiency across your organization.
A QMS is a structured framework of policies, processes, and procedures that organizations use to support and ensure that your products or services consistently meet customer requirements and regulatory standards throughout the entire product life cycle.
It encompasses all aspects of the organization’s operations, from management, product design and development to production, delivery, and customer service. Our QA/RA consultants will support you to set at a QMS suitable for your organization and product(s).
QMS pays off in the long run
- Increases internal efficiency, you do not have to reinvent the wheel over and over again
- Enables structured work and maintains improvements
- Creates trust in customers, suppliers and employees, which in turn improves profitability
- Is a visible proof that the company works in a structured way
- Knowledge is not linked to specific individuals and therefore always maintained within the company
- Established information flows reduce the risk of extra work and that important tasks are missed
- Identifies problems quickly and decisions can be made on well-founded information
Understanding Regulatory Requirements Across Borders
All companies at the Medical Device and In-vitro Diagnostics markets are regulated to have a QMS. The international standard ISO 13485:2016 is a good baseline but each market has its own requirements for a QMS.
GBA Key2Compliance supports you to find the QMS requirements on the markets of your choice.
Worldwide
ISO 13485:2016 is an international standard serving as a baseline for QMS all over the world.
You can get a certification regarding ISO 13485:2016 from a Notified Body or a certification company. A certification is a quality stamp for your company proving that you are fulfilling the standard.
GBA Key2Compliance supports you to get ready for a certification and also to keep it.
EU: Article 10 MDR/IVDR)
In Europe all companies at the Medical Device and In-vitro Diagnostics market are regulated to have a QMS that fulfills MDR/IVDR Article 10, regardless of risk class. MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation).
GBA Key2Compliance supports you to create an effective QMS for your type of products and your company size.
USA: Quality System Regulation (QSR)
In USA all companies in the Medical Device industry are regulated to fulfill 21CFR820. On February 22, 2022, the Food and Drug Administration (FDA) published a proposed rule to amend the current QSR regulation to harmonize with ISO 13485: 2016. The intent of the proposed rule is to align FDA’s regulatory framework with that used by other global regulatory authorities, promote consistency in the regulation of medical devices, and provide timelier introduction of safe, effective, high-quality devices to market. The proposition has not yet been effective.
GBA Key2Compliance supports you to create or update your QMS to fulfill the requirements on the USA market.
MDSAP
The Medical Device Single Audit Program (MDSAP) is a global initiative designed to promote more efficient and effective oversight of medical device and IVD manufacturers’ quality management systems. It is a cooperative arrangement between regulatory authorities from the USA, Canada, Brazil, Australia, and Japan.
GBA Key2Compliance supports you to create or update your QMS to fulfill the requirements of MDSAP
Exploring the Benefits of eQMS
Focalcube – An easy to use and competent cloud solution for quality management provided by Medos made available through GBA Key2Compliance.
Contact us
Whether you’re a startup building your QMS from scratch or a mature company looking to improve your existing system, our team of experts are ready to assist. Don’t let regulatory hurdles slow you down.
Contact GBA Key2Compliance today and let us help you navigate the path to compliance, efficiency, and long-term success.