As more innovative medical technology companies sprout up across the country, there appears to be a growing misconception among some of them that are new to medical device development and manufacturing relating to the regulatory requirements that their company needs to comply with. Even though original equipment manufacturers (OEM) may chose to outsource the manufacturing of their finished medical device to take advantage of the benefits of outsourcing, it is imperative that they understand the roles and responsibilities of both the OEM and contract manufacturer (CM) to ensure compliance. The finished medical device CM cannot absorb the compulsory duties of the OEM. OEMs (the company whose name will appear on the medical device) will always have some level of regulatory responsibility that cannot be relinquished or contracted away under any circumstances.
For example, OEMs would still need to maintain a Quality System commensurate with the level risk presented by their medical device and the size of their organization because they would still need to be compliant with design controls, CAPA, documentation control, complaint handling, etc. For example, FDA would require the OEM to have a system and procedure in place to analyze and trend customer feedback to ensure that any quality problems with their medical devices are being addressed in a timely manner. Regardless of where the quality problem originated, the OEM would still be responsible for implementing and managing any necessary remedial action.
In the eyes of the FDA, the OEMs are ultimately responsible for the quality and compliance of their medical devices. That is why it is so vital that they choose a trusted CM that is compliant to both the ISO 13485 standard and the FDA Quality Systems Regulation, 21 CFR Part 820, and thoroughly understands the regulatory requirements of both parties so that they can be an advisor and partner. Working with a trusted, compliant CM provides the OEM the reassurance that all the medical device manufacturing regulatory requirements are being considered and adhered to while they focus on the regulatory requirements that they are still required to comply with.
Cogmedix is a great partner because we understand our regulatory roles and responsibilities as well as the regulatory requirements of our customers and we can provide guidance and support throughout the entire process.