Loading...
Associates
Leonard (Leo) Eisner is the head of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical, in-vitro diagnostic, low voltage and other EU Directives . He has over 24 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service. Prior to that Leo worked in a cross section of groups at U.L. for 9 years. Leo is a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Medical Electrical Equipment). Leo is the convener of SC62D JWG9 – Lens removal and vitrectomy devices for ophthalmic surgery. Leo is a co-author of multiple articles on IEC 60601-1 as can be seen on the Featured Articles web page of this site.
Rebecca K. Pine has over 20 years experience in the medical device industry both at industry-leading corporations as well as small business start-ups. Her background includes all aspects of domestic and international medical device Regulatory/Quality management for a wide-range of products including cardiovascular, orthopedic, electromedical devices, nuclear medicine and in vitro diagnostics (IVD).
She has experience in all aspects of domestic and international Medical Device Regulatory management, including Quality Assurance and Quality Systems. She had compiled and managed submissions for 510(k)’s, PMA’s, Technical Files and Design Dossiers. She has background in Class I, II and III devices (FDA) & Class I, IIa, IIb, III devices (EU MDD) in the areas of hemostasis management, cold therapy systems, electro-medical devices (EMS/TENS), infusion pumps, and orthopedics devices including bracing (OTC and Rx), surgical instruments, as well as implantables, IVD’s, brachytherapy and mammography systems.
Alf Dolan has 35 years experience in the medical device & health care field in standards development, as a professor at Virginia Tech & University of Toronto, and in running a world class medical Safety Test Laboratory. He is the Convener of the Joint IEC/ISO Working Group 1 on the Application of Risk Management to Medical Devices, a joint working group between IEC Subcommittee SC 62A and ISO Technical Committee TC 210. This is the committee that published the world wide standard for all medical devices, ISO 14971; Risk Management for Medical Devices. Alf has been Chairman of various Canadian National Standards committees for 35 years and international committees for 15 years for ISO 14971. Alf is also Chairman of the IECEE ME Task Force and is charged with developing the implementation requirements for risk management certification in IEC 60601 Medical Electrical Equipment for the IEC CB Scheme. He set up and was corporate manager of the Health Care Technology Program for standards and certification at CSA for 6 years.
In addition to his vast standards experience he was responsible for developing and coordinating the Clinical Engineering Program at the University of Toronto. Alf, also has been the Technology Advisor to the Canadian Hospital Association and has represented the Association in other major Canadian health care bodies such as Health Protection Branch, Canadian Dental Association and the Canadian Standards Association.
Paul Fabry has over 30 years experience in the testing, assessment and certification of medical devices and in-vitro diagnostic equipment working at CSA-International. Paul has a broad range of knowledge with a variety of schemes of the conformity assessment (product safety) process worldwide. He is Chairman of the Canadian Committee of CNC/IEC TC66E; (Laboratory Equipment Standard IEC 61010-1), a member of CNC/IEC TC62, CNC/IEC SC62A and CNC/IEC SC62D (Medical Electrical Equipment Standard IEC 60601-1), a member of IEC TC66/WG1 and WG11, a Technical Advisor to the Chairman of CTL ETH3, a member of IEC TC62A/WG14, and a member of the Technical Committee of CSA on Medical Electrical Equipment.
Tom Odland, a former TÜV Product Service Lead Auditor and Regulatory Reviewer, has over 25 years in the medical device industry. Tom spent the first sixteen years of his medical device career as a Research Scientist at St. Jude Medical, Inc. and Manager of Research and Development at Bio-Vascular, Inc. His primary areas of concentration are cardiovascular implantable devices, products containing materials of animal origin, and vascular grafts. Tom holds eight US patents associated with these devices. Particular areas of expertise include CE-marking of high-risk devices, ISO 13485 certification, and the Animal Origin Directive, 32/2003/EEC.
Cheryl Weatherford has over 25 years experience in the medical device and pharmaceutical industry both at industry-leading corporations as well as small business start-ups. Her background includes all aspects of domestic and international medical device Regulatory/Quality management for a wide-range of products including ophthalmic drugs and devices, cardiovascular implantables, electromedical devices, laboratory equipment, and biologicals. Key skills and experience include PMA, 510(k), and Design Dossier submission writing, regulatory compliance and the development/management of quality systems which comply to ISO 13485:2003, ISO 9000:2000, CMDR, MDD, and 21 CFR 820.
Harvey Rudolph has over 30 years in the medical device industry. He was the global program manager in the UL Medical Business Unit for seven years and worked for the FDA in a variety of positions for 25 years. Harvey’s background is in all phases of global device regulatory requirements. He is a risk management expert, have provided risk management training, consulting, and auditing services for a large number of medical device companies. Currently, he co-chairs the US Technical Advisory Group for the ISO/IEC Joint Working Group 1 on Risk Management and authored a significant part of ISO 14971. He also is a member of ISO/IEC JWG3 on software, IEC 62A WG15 on risk management, and the IAF Working Group on the global medical device conformity assessment system. In 2004, he was listed in MDDI a one of the Top 100 Notable People in the medical device industry
Anna Christensen has over 15 years of experience in regulatory affairs and quality assurance processes. She has managed various aspects of regulatory and quality project development, from product concept through product launch in both domestic and international markets. A significant portion of her career has been in the area of minimally invasive cardiovascular products and permanent implants. Key skills and experience include PMA, 510(k), IDE and Design Dossier submission writing; project management; regulatory compliance; quality system development; and quality system auditing.
Michael Wienholt has over 20 years experience in the medical devices and in-vitro diagnostic industries in various roles, including product development, manufacturing, quality and regulatory affairs. Michael has over 10 years of direct experience in a regulatory affairs role in FDA-regulated industry. Michael is knowledgeable in the regulatory requirements for devices and diagnostics in the major Outside of US markets, and has obtained market clearances in a number of foreign countries. He is RAC certified in both United States and European Union regulatory affairs by the Regulatory Affairs Professional Society (RAPS). He is a member of the American Society of Quality (ASQ) and is an ANSI/RAB accredited auditor of quality systems for the medical device industry.
James (Jim) Sandberg is a registered professional engineer in the state of Oregon and has over 30 years of regulatory compliance experience. He was the Director of Regulatory Affairs and Compliance Engineering for Welch Allyn Protocol, Inc., a Beaverton, Oregon based manufacturer of medical instruments and systems. Jim is a member of the Editorial Advisory Board and Technical Advisory Board for MD&DI magazine. Jim was Director of Sustaining Engineering at SpaceLabs, Inc. before joining Welch Allyn Protocol. Prior to SpaceLabs, he was Quality Assurance Manager in the Tektronix, Inc. Medical Instruments Division where he was responsible for ensuring compliance with Food and Drug Administration regulations.
Mark Roberts is a certified lead auditor, and CE marking and product sterilization expert. He has over 25 years of medical device industry experience. Previously he was the head of western United States operations for TÜV Product Service. Prior to that he was Manager of Quality System for Becton Dickinson and Sterility Assurance Manager for Baxter Healthcare, Bentley Division.
Bob Weiner has over 20 years experience as a laser expert and has assisted more than 700 laser product manufacturers with US, European, and international laser requirements. He is an active member of the IEC TC-76 committee that is responsible for international laser safety standards, and he leads the U.S. delegation to the yearly meetings of that committee. He is also an active member of the ANSI Committee for the Safe Use of Lasers and the laser safety committee of the Laser Institute of America, and he has chaired sessions and participated in expert panels at the International Laser Safety Conferences.
Lori Wyman handles all the customer service, administration and billing activities for ESC. She has worked in a variety of professional firms and is here to support you, our customer.
ESC also works with other consulting groups and companies to provide additional services. Visit our affiliates page.
