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