A medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following purposes:
Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
Investigation, replacement, or modification of the anatomy or a physiological or pathological process
Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations
These devices do not achieve their primary action by pharmacological, immunological, or metabolic means but may be assisted by them.
Also considered medical devices:
We offer a complete range of medical device regulatory consultancy services designed to help you manage the challenges of compliance and bring your products to market efficiently.
Ensure medical devices meet the required high standards, comply with ISO regulations, and pass audits with confidence.
Guide your product from concept to market while aligning with complex regulatory frameworks like MDR, IVDR, and UKCA.
Gain clear, practical guidance on medical device regulations through expert-led training tailored to your experience level.
Secure entry to your target market and gain access to public/private funding with our strategic consulting.
✱ Helping you reach the market faster with funding-ready strategies.
Meet EU and UK regulatory obligations with expert PRRC oversight and trusted EUAR/UKRP representation for seamless compliance.
✱ Your single point of contact for regulators and local regulatory duties.
Ensure your manufacturing processes, equipment, cleaning, and test methods are fully validated to meet consistent, reliable quality standards.
25+ Years of Regulatory Experience
Adnan is the founder and lead consultant at Simplimedica, bringing decades of hands-on experience in regulatory affairs and quality assurance. With a deep understanding of medical device, pharmaceutical, and diagnostic regulations, he has supported over 100 companies in navigating complex compliance requirements and achieving market success.
His mission is simple: to make regulatory clarity accessible — so you can focus on innovation.
www.topra.org
www.nexusleeds.co.uk
www.medilinkuk.com
Simplimedica is a consultancy firm that believes in long-term partnerships. We support short-term, medium-term, and long-term project work for small medium-sized businesses as well as large corporations. You may have a shortage in skill or wish to outsource some work that may be more productive. Simplimedica has experience in a number of Pharmaceutical and Medical Device companies including some of those on our client list page.
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