RSC Mason obtained certification under the ISO 13485:2016 standard on January 24, 2023. This standard sets forth the requirements for a Quality Management System (QMS) in the design and manufacturing of medical devices. To achieve certification, an organization's QMS must successfully pass a third-party Medical Device Single Audit Program (MDSAP) Audit. This certification ensures that Festo can consistently provide medical devices and related services that meet both customer expectations and any relevant regulatory requirements, by demonstrating its ability to implement a QMS. Ultimately, the goal is to generate qualified leads from customers who require products for the production of medical devices.
Product families produced under the new certified process:
- VZXA Polymer & Brass
- PGVA-2
- DHOE Open Loop Pipette
- VTOI/VTOE
- PGVA-1
- Tip Ejector Mechanism