- Pharmaceutical Consultancy
- Medical Devices
Medical Devices
FQS support the implementation of a Quality Management System for manufacture and distribution of Medical devices in compliance with Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) and ISO13485:2016
We offer several services, tailored at your needs:
MDR Transition
- This service was design to allow your company to understand the MDD/MDR Gaps, define an action plan and have a team of experts supporting implementation.
QMS and Regulatory Support
- Regulatory assessment and support
- PRRC support (only available for micro or small enterprise, according to art.15 MDR, with NB pre-approval)
- Quality Management System Implementation (for new systems)
- Quality and Regulatory compliance assessment and Reviews (for existing systems)
- Investigations, Closure of CAPAs and non-conformances
- Consultancy Work
- Training
QMS Activities Support
- Auditing (cGMP/cGDP/cGLP)
- Service providers approval
- Risk assessments
- Improvement projects and investigational work
- Investigations, Closure of CAPAs and non-conformances
- Consultancy Work
- Training
