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

On the Phone

+44 1273 704 527 UK

+353 91 428070 IRL

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