Always ready for inspection:
Expert QMS Solutions for Medical Device and IVD Manufacturers

In the development of medical device, IVD and company strategies, an effective Quality Management System (QMS) is the key to long-term success. An effective QMS will make you more ready for the challenges ahead; you will have systems to catch future issues before they become problems and you will be able to plan for necessary changes well in advance. Investing in an effective QMS increases the value of your company and reduces stress for you and your employees. You will always be ready for inspection, and you can welcome the unannounced auditor with a smile.

Quality Management Systems

Key2Compliance offers a wide range of QMS services. For startups we can, together with you, build your QMS from scratch. For more mature companies we can help you with internal audits, GAP analysis, non-conformities, increase of effectiveness or give you a QA/RA refreshment.

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. 

Key2Compliance supports you to find the QMS requirements on the markets of your choice. 


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.  

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). 

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. 

Key2Compliance supports you to create or update your QMS to fulfill the requirements on the USA market. 


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. 

Key2Compliance supports you to create or update your QMS to fulfill the requirements of MDSAP

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 

Exploring the Benefits of eQMS

Focalcube – An easy to use and competent cloud solution for quality management provided by Medos made available through 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 Key2Compliance today and let us help you navigate the path to compliance, efficiency, and long-term success. 

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