anteris medical’s expertise contributed to the successful development of an class IIa Medical Device
For an EU based Medical Device company anteris medical was responsible for a significant portion of the device development for a class IIa device. Particularly, anteris medical consultants did not only take over the project management of the life cycle management of an existing device, but also established the required design control documents in compliance with EU and US requirements. The change from one Notified Body to another was only one of the initially unexpected hick-ups which were successfully managed by anteris medical. In order to facilitate the technical documentation a document management system was implemented in order to electronically establish and publish design control documents – not to forget the tool selection and QMS implementation which came along with this initiative.
As the development for this device was outsourced to multiple vendors, anteris medical needed to also support supplier selection and supplier management processes.
- Medical Device
- Design Control
- Medical Device Regulation
- Medical Device Directive
- Quality Management System
- Document Management System
- Supplier Management
- Managing 4 suppliers at once
- Transfer from one Notified Body to another
- Establishment of a Document Management System
- Deep understanding of Design Control compliant to US and EU requirements
- Hands on mentality to get the development compliant to meet different regulatory requirements
- End to end support from project definition through the operational development to final release of the product