In order to place a medical product on the market you are required, by law, to ensure that the product is designed and manufactured in accordance with the requirements of that territory. Failure to comply with these regulations may have significant implications, so selecting the right manufacturing partner is essential.
But what will the right manufacturing partner look like? When creating the design specification it is essential to identify the classification of your product within your chosen geographical markets. This dictates the standards to which your product must be manufactured. The next stage is to ensure that your manufacturing partner can meet the regulatory requirements of those territories and that it has the skills to manufacture your product, either in house, or via approved subcontractors.
A full supplier audit is essential, with particular attention to documentation control, record control, infrastructure, and the procedures associated with monitoring and measuring conforming and non-conforming product and complaints/returns.
Control of infrastructure is heavily referenced throughout medical product legislation with regard to the processes, maintenance of manufacturing equipment, training and the manufacturing environment, all of which should be stringently controlled. These processes should feature within your audit.
Controlling non-conforming product, and identifying it early, is something your manufacturing partner should be able to do. Their procedures or key process indicators (KPI) should record any failures and monitor for early identification of trends. Traceability should then reveal the serial numbers affected.
Controlling the manufacturing process required for medical products is covered by law in most, if not all territories, so selecting your partner is a major consideration and should be based on the company’s skill set and its ability to comply with the legislation.