Mantra Systems
↗Sheffield, United Kingdom
Mantra Systems is a specialized medical device regulatory consultancy based in the United Kingdom. The firm provides comprehensive technical and clinical support to medical device manufacturers, helping them navigate the complexities of the EU Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR), and UKCA marking requirements.
The company distinguishes itself by employing a team of MDR-trained medical professionals and clinicians who apply clinical acumen to regulatory challenges. Their services include the authoring of Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans, and providing strategic market access advice for manufacturers ranging from startups to multinational corporations.
CLASSIFICATION
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$5M
Founded:2019
Ownership:private
Status:operating
FUNDING
Stage:Bootstrapped / Private
PIPELINE
Stage:Commercial
Lead Drug Stage:N/A (Service Provider)
Modalities:Medical Devices (Class I, IIa, IIb, III), Software as a Medical Device (SaMD), IVD
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Key Partnerships:NHS Clinical Entrepreneur Programme (Official Programme Partner), TOPRA (The Organisation for Professionals in Regulatory Affairs)
COMPETITION
Position:Niche Player
Competitors:NAMSA, RQM+, ICON plc (Regulatory Division), QES Medical, Red Medtech
LEADERSHIP
Key Executives:
Dr. Paul Hercock - CEO
Richard Jones - Operations Director
Sandra Gopinath - Chief Regulatory Officer
Scientific Founders:Dr. Paul Hercock
LINKS
Website:mantrasystems.com
LinkedIn:LinkedIn Profile
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