Regulatory assessment of medical device development has become increasingly stringent, with differing frameworks and requirements across the UK, EU, and US markets. However, all jurisdictions demand high-quality clinical studies for medical device approval.
End-to-End Regulatory and Clinical Support
The Micron Group supports medical device companies with expert regulatory consulting, clinical trial design for medical devices, full clinical trial management, and submission-ready reporting.
Navigating regulatory complexity with clarity, experience, and compliance.
Proven Experience Across IVD and Therapeutic Devices
We have recently supported the development of devices in wound healing and in-vitro diagnostic (IVD) medical devices, including a point-of-care device for influenza and RSV detection and a system for rapid antimicrobial susceptibility testing.
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Get in touchOur Offices
Micron Research
109B Lancaster Way Business Park
CB6 3NX, Ely, Cambridgeshire
England, United Kingdom
US Micron
12022 Blue Valley Parkway, Overland Park
Kansas 66213, United States of America
Clindev
5 Regency Drive, Building C, Route 21 Corporate Park Irene, South Africa
EU Micron
Harju maakond, Tallinn, Kesklinna linnaosa
Viru väljak 2, Tallinn 10111, Estonia
LogicTrials
9 Regency Drive, Building B, Route 21 Corporate Park
Irene, 0157, South Africa
Services
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Integrated Clinical Development Services
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Drug Distribution and Logistics
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Software
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