Our team have over 25 years’ experience working in medical device quality assurance and regulatory compliance. All our team members have industry experience, working in SMEs, large corporate organisations, notified bodies and the MHRA.
Patient Guard offers a free consultation to collect all data required to build your personalised package as well as ensuring all regulatory responsibilities are met throughout the business. Our consultants have the qualifications and experience to offer Qualified Person services in accordance with MDR, along with their collective knowledge and on-going industry contracts to ensure we can always offer the most up to date advice. You will also be saving money working with us as to hire a Quality Assurance Manager and Regulatory Affairs Manager can be very costly. The average cost of employing a Quality Assurance Manager in the UK is £41,650 (glassdoor.co.uk, 2018) and for a Regulatory Affairs manager in the UK is between £50,000 to £70,000 (prospects.ac.uk, 2018), that’s without any other benefits they may require.
Patient Guard will always be available as a point of contact, we will be more than happy to give you free ad hoc advice via email and phone whenever you need it throughout your contract.
David Small, Company Founder & Owner of Patient Guard Limited. David has 5 years’ experience leading the development of medical devices in the industry, 2 years’ experience working at the MHRA as a higher medical device specialist, 2 years’ experience working in the NHS as a Biomedical scientist, a PhD in analytical chemistry, a Masters Degree in analytical Bio-science and Drug design BSC (HONS) in Biomedical science.
“Over the next few years industry is going to feel the burden of implementing MDR and IVDR, which is why I started Patient Guard. I believe SMEs can really benefit from a company that can tailor QA & RA services around there unique needs in developing and selling Medical Devices”.