Quality Management Services
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
Our colleague, Louise Hollywood has written a blog called 'The Crucial Role of Quality Management Systems and ISO 13485 for medical device manufacturers'. You can read Part 1 here:
