The term “Legal Manufacturer” refers to the entity taking responsibility for the medical device for regulators. This entity may not actually manufacture the device, it might be done by one or more vendors at the “Legal Manufacturer’s” behest, but this is the name on the label and the entity that regulators will record as responsible and where needed, audit. This entity needs to have the required Quality Management System (QMS) in place to satisfy, usually, ISO 13485 and 21 CFR 820 for most jurisdictions.

Establishing this QMS is a service we can provide for you as consultants, but it is an arduous path, takes a long time and costs a significant amount of money – money that is spent on the QMS, not developing your device. As an alternative Vestech Medical, through its sister company Cryptych P/L, can act as your “Legal Manufacturer” as a bridging strategy. You still own your device and IP, you are still going to be the Legal Manufacturer, but you can get onto the market and sell your device before your QMS is ready for that step. It can save years.