Alex Grob

Alex Grob

  • Technical expert for the medical IEC 60601-1 series of standards
  • Technical expert for the laboratory equipment IEC 61010-1 series of standards
  • Technical expert for the risk management and software process standards
  • Evaluation and testing of medical equipment to IEC 60601-1series of standards
  • Evaluation and testing of laboratory equipment to the IEC 61010-1 series of standards
  • Training and seminars on the medical standards

EDUCATION

Milwaukee School of Engineering (MSOE): BS in Biomedical Engineering

STANDARDS COMMITTEES

– US Expert for IEC SC 62A MT 28 Convener (IEC 60601-1 Electrical hazards)
– CO-CHAIR of AAMI ES (Electrical Safety) Committee, (responsible for AAMI ES 60601-1)

PRIOR TO MECA

GE Healthcare: Director, Regulatory Affairs – Standards

  • Defining & implementing internal process & tools for the identification of global standards requirements
  • Primary technical resource for interpreting standards and their relationship to global regulations
  • Develop and present standards related training for employees

Underwriters Laboratories Inc.: Medical Device Services Reviewer and Sr. Project Engineer/Quality System Auditor

  • Evaluation, full testing, and documentation of medical equipment to UL, IEC, EN, and CSA medical standards
  • Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program
  • Primary Instructor for UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
  • Technical Expert for European Medical Device Directive (93/42/EEC) Audits (for CE Marking)
  • ISO 9000/ISO 13485, CMDCAS, and EU MDD Annex II/IV Quality Systems Auditor

ABOUT

Alex is a biomedical engineer that has been working in the medical field for the last 20 years.  Alex has experience as a quality system auditor, 3rd Party 501K reviewer, notified body auditor & technical assessor, testing laboratory engineer, regulator affairs director and is currently the Chief Biomedical Engineer & Assistant Quality manager at MECA.  Alex is involved in the standards development process as the Convener of IEC SC62A MT28 for electrical hazards as well as the Co-chair of AAMI-ES, these committees are responsible for IEC 60601-1 and the US adoption ANSI/AAMI ES 60601-1.

2019-06-27T21:29:37+00:00March 26th, 2019|

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