For many start-up companies, outsourcing manufacture is the only viable method of developing their product and getting to market. The industry directives and regulations (e.g. MDD, IVDD, CMDCAS etc.) define the company who puts the product on the market in their own labelling as ‘The Manufacturer’ irrespective of who actually made the device; 'The manufacturer' is solely responsible for the safety and efficacy of the finished device. It is of the utmost importance therefore, that control is administered over your critical suppliers.
QMS Consultancy can manage the following activities on your behalf:
- Quality Agreement. The production of a 23-page contractual document outlining roles and responsibilities.
- Supplier Audits
- Development of material / product specifications.
- Project Management
Contact us today to see how we might help you!.