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Supporting All Aspects of Medical Device Development and Production
Process Development
* Coordinate and lead the creation of product development processes compliant with the appropriate standards and regulations. * Compliance evaluation – gap analysis of procedures and processes. * Development of the capacity to certify products (apply safety marks) in-house.
Device Compliance: * Device Standard / Design Gap Analyses * Identification of Applicable Standards * Equivalent Safety Analyses * Interface with Certification Bodies
Liability:
* Independent product safety evaluations * Establishment of “state of the art” for safety of specific products * Support during discovery * Expert witness
Licensing and Acquisitions:
* Due diligence audits (products and organizations) * Market opportunity evaluations
Developing new markets:
Evaluation of new foreign markets and entry strategies to penetrate them· Identification of regulatory requirements and approval strategies · Identification of local partners/representatives · Development of customer profiles · Coordination of strategic execution of your plans
Mike W. Schmidt Principal Consultant Strategic Device Compliance Services
Experience:
· International Electrotechnical Commission (IEC) 1993 / Current - Former Convener, IEC SC 62D WG10; IEC 60601-2-38 Particular safety requirements for electrically operated hospital beds. - Convener, IEC SC 62A MT 30; IEC60601-1: Section 6, Protection against hazards of ignition of flammable anaesthetic mixtures & Section 7, Protection against excessive temperatures and other safety hazards. - Expert member, IEC/SC 62A MT 31 (60601-1-4 Programmable electrical medical systems) - Expert member; IEC/SC 62A MT 27 & ISO/IEC JWG 1 (Risk management- ISO/IEC 14971). - Member: IEC/SC 62A Chairman’s Advisory Group: Management team for rewriting of IEC 60601-1 General requirements for medical electrical equipment. - Secretary, IEC SC62D; Subcommittee assigned to create electrical safety standards for specific medical device categories
· Association for the Advancement of Medical Instrumentation (AAMI) 2003 / Current - Co-Chair Electrical Safety Committee
· National Fire Protection Association (NFPA) 2007 /Current - Committee member NFPA 99 Committee
· Ethicon Endo-Surgery: Sr. Standards Compliance Associate 1999 / Current - Consult with Licensing and Acquisitions Teams regarding product & process compliance. - Develop product compliance processes that acceleration of Regulatory approval and compliance certification. - Advise & support design teams on the selection of standards and specific application of requirements. - Advise & support the Regulatory Affairs team on issues of compliance and international regulatory requirements. - Provide in-house training on issues of standards development and application to medical devices. - Maintain company’s standards database & assure compliance w/ document control requirements of ISO 9001 & Annex 2 of the Medical Devices Directive. - · Hill-Rom Company Incorporated 1983 / 1999 o International Regulatory Affairs 1990 / 1999 - ISO 9001/13485 (design & development process, documentation and training) - Medical products standards compliance issues (IEC, UL, CSA, CEN & CENELEC) - International medical device law compliance (outside of North America) - Compliance issues related to the European directives
Skills: · · Negotiation and mediation of international business, technical and political issues (Europe and Asia). · · Writing of international and domestic standards, quality systems procedures and compliance documents. · · Development and execution of training programs (Hill-Rom, Ethicon Endo-Surgery, US Food & Drug Administration, AAMI, Advamed). · Speaker and consultant on issues of device regulation and standards compliance with International Medical Device Law including the European Medical Devices Directives, device safety standards and compliant design control systems. Venues include: Association for the Advancement of Medical Instrumentation (AAMI) conferences, Advamed (formerly Health Industry Manufacturers Association), Israeli Standards Institute, British Standards Institute (BSI), Guangzhou Medical Instrument Test Center (China State Food and Drug Administration. · Member: AAMI Standards Board; AAMI International Standards Board ; AAMI Nominating Committee (1998-2001) –Board level management · Co-Chair: AAMI Electrical Safety Committee – Committee level management · Secretary IEC Subcommittee 62D (device specific safety standards) – Coordination and management 22 working groups and project teams responsible for the development and maintenance of over 50 device standards. Education: · BS - Business / Economics - Mt. St. Joseph College (Cum Laude) - Aug. 1995 · ASEET - Electronic Engineering Technology - University of Cincinnati / O.C.A.S. - 1974 · Professional Training: Change Management, Team Building, Product / Service Development Systems (QFD), the Liability, Product Safety, EMC and Medical Device Directives (Europe).
Strategic Device Compliance Services
Principal Consultant:
VOICE: +1 (513) 236 5907 FAX: +1 (866) 3606803
2087 West Fork Rd. Cincinnati, Oh. 45211 USA
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