The Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR) now include regulation on manufacturers having a Qualified Person.
Our Qualified Person Service ensures that the companies technical files and regulatory obligations are carried out. This does not mean that the company has to employ a regulatory person to perform this service, as this is unlikely to be a full-time role for a small medical device company.
It is possible to contract out this position to a 3rd party company – with a consultant managing the system on a few days per month basis. We would be more than happy to discuss this option with you, helping you to find a consultant with the necessary qualifications to perform this service effectively. If you would like to know more about this service, then please contact us.