Quality First International (QFI) is a global consultancy specialising in medical device regulation and compliance. Since 1995, we have supported clients across the UK, Europe, the U.S. and Canada, ranging from start-ups to multinationals.

We help bring your medical device to market by solving regulatory, technical and compliance challenges with deep industry expertise and hands-on support.

Our core services include:
•	Global regulatory & compliance strategy
•	Product development & scientific support
•	Microbiology & biocompatibility
•	Quality Management Systems
•	EU Authorised Representative & UK Responsible Person
•	Device registration & clinical trials

Technologies we support include:
•	Cosmetic & combination products
•	Cardiovascular & minimally invasive devices
•	Implants & animal-derived devices
•	PPE, clinical monitors and more

Whether you need guidance on a single submission or end-to-end QMS implementation, QFI has the experience to help you navigate complex regulatory pathways with confidence.

Quality First International

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Quality First International

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