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Welcome to our new four part video series which provides an overview of the importance of a

Quality Management System (QMS) in the medical device industry. 

Video 1: Why medical device manufacturers need a QMS

Video 2: The importance of ISO 13485

Video 3: Overview of key parts of the ISO 3485 standard

Video 4: Introducing CompanionQMS

Psephos has decades of experience obtaining regulatory approvals for medical devices. We help clients develop a regulatory strategy with an action plan, which we can help implement. The strategic implementation of the right QMS at the right time for your medtech venture is what Psephos offers, from concept to commercialisation and beyond. 


Psephos provides the following services to our clients:

- Identification of appropriate QMS standards (e.g. ISO 13485) and regulations (e.g. EU MDR) that apply to your company and device

- Tiered approach to writing, implementing and operating your QMS

- Integrated Document Control and Related QMS Activities Service

- Auditing and Corrective Action Planning and Implementation

- Training and development of your team to gain the most from the use of your compliant QMS



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