Medical device manufacturers continue to outsource larger parts of their development and production. And these manufacturers must show that they have sufficient control over their suppliers. This often leads to situations where medical device regulations are simply dropped at the supplier and compliance is expected.
Grey RA promotes an alternative in 3 steps:
- The manufacturer determines the exact risk of the outsourced activity.
- The manufacturer consults with the supplier and the required control (including those parts of regulations that apply) is defined and documented.
- The supplier ensures compliance and escalates any compliance issues to the manufacturer.
Grey RA understands medical device regulations and can support both suppliers and manufacturers with all three steps. Interested? Contact Grey RA today for a free introduction in the possibilities.