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Kevin Butcher

Principal Regulatory Consultant

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Kevin is a 20-year veteran of the medical device industry, both with Notified Bodies and in industry with primary industry experience in active devices.

Kevin’s career experience includes positions at Gambro Ltd and Elekta Ltd before joining AMTAC/Intertek in 2003 where he oversaw and conducting Product Conformity Assessments audits and Technical Documentation reviews against European Directive 93/42/EEC requirements. Following, Mr. Butcher moved into management positions within Notified Bodies (AMTAC/Intertek & SGS United Kingdom Ltd) with roles in operational and technical areas, eventually becoming Certification Manager for SGS United Kingdom and SGS Belgium Notified Bodies.

Kevin joined NAMSA in January 2021, the focus of his work is on complex regulatory submissions for active devices, including, development of regulatory and clinical strategies and MDR transition strategies; technical documentation compilation; MDR QMS transition consultations; the new United Kingdom UKCA regulatory process; and regulatory due diligence.

CORE COMPETENCIES

  • Certification Manager, Operations Manager and Technical Manager of Notified Bodies SGS UK 0120, SGS Belgium 1639 and AMTAC/Intertek 0473
  • Management of Notified Body certification and regulatory/technical decisions, including the independent technical review process
  • Notified Body operational management, inclusive of competence management of Product Assessors and Lead Auditors
  • Review of technical documentation as a Notified Body Product Assessor and on-site QMS audits as a Notified Body Lead Auditor to support CE-marking over 17 years; experience in both areas in multiple geographic areas (Europe, North America & Caribbean, Africa, Middle East, Indian sub-continent, China, Taiwan, Korea and Japan)Management of external experts and subcontractors
  • Stakeholder/relationship management  with UK Competent  Authority Medicines and Healthcare Products Regulatory Agency (MHRA)  and   EU Commission
  • Served as Deputy President of Team-NB and Manager of Team-NB Notified Body Code of Conduct process
  • Member of EU Commission Medical Device Coordination Group (MDCG) working groups on Borderline, Classification and EUDAMED UDI
  • Member of MDSAP Registrars Forum 2015 to 2017 and management of SGS UK approval as a MDSAP Auditing Organization (AO)
  • Preparation and coordination of responses to regulatory agencies (EU, MDSAP and Health Canada)
  • Senior member of SGS UK 0120 MDR Designation Team
  • Management of TCPII & TCPIII mutual agreement process between the EU and Taiwan (TFDA)

RECENT PROJECTS 

  • Medical Device Regulation (MDR) QMS Gap Analysis audit in preparation for Notified Body initial audit in early 2022
  • MDR transition project rectifying weaknesses in a Client’s Technical Documentation and QMS for submission for MDR certification
  • Development of a clinical strategy for MDR submission for a change of intended use under MDD certification, where the classification of the device changed from Class IIa to Class III