Are you looking to implement an ISO 13485 compliant Quality Management System, or to strengthen quality processes you already have in place?
Compliance Management Solutions helps medical device manufacturers establish practical, compliant and audit ready quality management systems that fit the business rather than sitting on top of it.
Our QMS implementation services
- Complete ISO 13485:2016 QMS implementation
- Quality manual and procedure development
- Risk based process mapping
- SOP, form and template creation
- Design and development process implementation
- Supplier and purchasing controls
- CAPA, complaint handling and post-market surveillance processes
- Internal audit preparation
- Management review implementation
- Staff training and ongoing compliance support
Who this suits
This work is typically valuable if you are launching a new medical device company, preparing for ISO 13485 certification, expanding into international markets, transitioning to MDR, IVDR, MDSAP or TGA compliance, or improving a quality system that has grown organically and no longer reflects how the business actually operates.
A quality management system should meet the regulatory requirement and improve how the organisation runs. To discuss implementation, please contact our regulatory team.