All manufacturers should have at least one person available within their organisation who is responsible for medical device regulatory compliance and possesses the requisite expertise in the field of medical devices. Rather than paying a full-time qualified person to work for your company, turn to Patient Guard Ltd. Based in Blackpool, Lancashire, we have the knowledge and expertise to act as your organisation’s QP.
The requisite expertise for a qualified person must be demonstrated in one of two ways. They are:
a) A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the member state concerned in law, medicine, pharmacy, engineering, or another relevant scientific discipline, and at least 1 year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
b) 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.