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Home  >  Speakers  >  Mika Reinikainen
Mika Reinikainen

Mika Reinikainen

    LLM, MBA
Founder, Chairman, Managing Director | Surrey, England    United Kingdom
Healthcare Management
Healthcare Management, Medical Devices,...More
Spoken at 2 events

Biography :

Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (AAR). He is the founder of Above Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company focuses on regulatory strategy and compliance, as well as resolving manufacturers’ conflicts with Notifies Bodies and Competent Authorities. He also provides regulatory interpretation and advocacy, in particular on borderline determination between legal regimes.

Mr. Reinikainen has more than 30 years of experience in the European medical device field: as regulatory affairs manager in the industry (Pfizer Hospital Product Group of companies), as healthcare legal counsel (Hogan & Hartson) and as-as a regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles).

He was directly involved in the development of the Medical Devices Directives (chairing the working group that developed the European medical device classification system and later as a consultant to the European Commission on classification) as well as through various roles in trade associations. He also served as the former Chairman of CEN TC 257 (technical standards).

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Specialties

Healthcare Management

Interested Topics

Healthcare Management, Medical Devices, Pharmaceutical Industry, Clinical Trials, Due Diligence, Biotechnology, Quality Systems

State Licenses

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Board Certifications

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Professional Association

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Languages

English, German, French, Dutch, Italian, Russian, Portuguese, Finnish, Romanian, Estonian

Conference Session Materials

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