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 device EU Directives. Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He has 30 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 co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, 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 (Electromedical equipment). He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”. Leo is a member of the TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.) To support the increase in demand for medical device Home Use and Wearables Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living SycC (System Committee for all devices in various categories for the elderly which includes the home use medical device industry).
Home use medical devices has exploded of late in the medical device industry. To support this shift in the medical device market Leo is a member of the AAMI committee for Home Use Medical Devices and the US TAG for Active Assisted Living Syc (System Committee for all devices in various categories for the elderly which includes the home use device industry). Leo is a co-author of multiple articles on IEC 60601-1 as can be seen on the Featured Articles web page and is on the Editorial Advisory Board for MD&DI. Leo has audited for several EU Notified Bodies and has been a technical reviewer for Medical Electrical Equipment. Leo is the manager of a LinkedIn Group – IEC 60601 Series – Medical Electrical Equipment
Mary Weick-Brady is a former senior policy advisor with the Food and Drug Administration in the Center for Devices and Radiological Health. Ms. Weick-Brady chaired the CDRH Home Health Committee that focused on policy for the safe migration of medical devices going into non-clinical environments. She developed the guidance document for Design Considerations for Devices Intended for Home Use, represented the US on the ISO/IEC 60601-1-11 standard for home use medical equipment, and represented the home use perspective of the FDA both nationally and internationally at conferences and at regulatory meetings. As a co-chair of the AAMI committee on home use, she led the group to develop a Technical Information Report (TIR49) on patient labeling, and she led the efforts to adapt 60601-1-11 to US policy. Ms. Weick-Brady also led the Home Use Initiative at CDRH which was announced in April 2010. She has been a member on various governmental and non-governmental committees for policy on home use including the National Academy of Sciences, Center for Medicare and Medicaid Services, and the National Institutes of Health. Ms. Weick-Brady has published numerous articles on home use medical equipment.
In addition to developing regulatory policy on home use, Ms. Weick-Brady is experienced in guidance development, regulations, and standards. She assisted with the human factors guidance, the proposed rule on symbols recognition, symbols standards, and also performed numerous studies on a standard content of labeling for both the health care professional and the patient.
With 25 years of experience at the FDA, and over 30 years of experience as a registered nurse, including 6 years as a home health care nurse, Ms. Weick-Brady is able to provide training on home use policy, assist with premarket submissions intended for home use, and help industry understand the regulatory process.
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.
Dan Modi has 25+ years’ experience in the field of EMC Engineering, Electrical Safety Certifications, and Regulatory Compliance for international markets. Dan’s certifications include Regulatory Affairs Professional Certification (RAC – U.S, Canada & EU), Certified EMC Engineer (NCEE), Certified Safety Engineer (NCSE) and Certified Quality Auditor (CQA).
Dan worked at Alcon (Surgical Division) for over 17 years in charge of its Compliance Engineering Group, responsible for EMC, Electrical Safety, Reliability and System Verifications & Validations. His experience and responsibilities also included developing Global STeD, internal & external audits, standards management, managing risk management, design quality, and global registrations (working with corporate & international affiliates). Prior to Alcon, Dan was Engineering Director at a consulting & testing house for 9 years in charge of EMC & Electrical Safety certifications and regulatory compliance.
Dan has presented widely at conferences & company-wide trainings, and written articles for magazines like MD&DI. He regularly teaches Regulatory & other courses for the UCI, ASQ, etc. Through his involvement with various institutions, Dan has also consulted over the last 10 years on simple to complex medical devices, and has worked with start-ups to fortune 500 companies.
Dale Hallerberg has over 30 years experience in the safety and conformity assessment industry. He was the Principal Engineer for TUV Rheinland, leading their worldwide medical testing technical staff. He was also a Senior Staff Engineer in the Medical Devices Group at UL. Dale’s background is in the risk management requirements (ISO 14971) for medical electrical equipment (IEC 60601 series standards) having provided risk management training and consulting for medical device companies. Currently, he is a member of the CB Scheme Risk Management Task Force, and IEC Working Group 14 on Device Testing.
Dan Hoolihan has more than 45 years EMC experience working in the medical device, ITE and defense industries. He has been consulting in EMC Engineering for 15 years. He specializes in EMC-Laboratory evaluations, EMC standards, & EMC Education. Dan is a consultant to the US Dept. of Commerce National Institute of Standards and Technology (NIST) in the area of Telecom Certification Body (TCB) & Conformity Assessment Body (CAB) evaluations. He also assists on the NIST National Voluntary Conformity Assessment Systems Evaluation (NVCASE) Program. Also he is an assessor for NIST National Voluntary Laboratory Accreditation Program (NVLAP) for EMC/Telecom.
He was VP of Minnesota Operations for TUV Product Service (TUV America) from ‘94 to ‘00. The 10 yrs prior he was the Co-Founder & COO of AMADOR Corp.; a small business specializing in EMC testing of electronic products ranging in size from pacemakers to supercomputers.
He is presently the Chairman of the US ANSI- Standards Committee C63 on EMC. He has been on the Board of Directors of the IEEE Electromagnetic Compatibility Society (EMCS) almost continuously since ‘88. He is the past-president of the EMCS (‘98-‘99) & has held many positions with the EMCS Board in his years of service. He served as the Chair of the 2002 IEEE International Symposium (Minneapolis) on EMC.
Darryl Ray has more than 35 years EMC experience working in the medical device, ITE and defense industries. Darryl has performed EMC engineering on well over 100 products and has built 8 complete EMC labs from scratch. Darryl is an active member of IEC Maintenance Team 23 pertaining to the development of IEC 60601-1-2 and also a member of the US national committees for CISPR 11, 22, 24, 32 and 35. He is an iNarte Certified Master EMC Design Engineer. Darryl has authored several papers for past IEEE EMC symposiums. He is a Senior Member of the IEEE and former chair of the IEEE Santa Clara Valley EMC chapter.
Bruce Nelson has over 17 years experience in the medical device industry at a number of industry-leading corporations and small business start-ups. Bruce’s expertise include DHF development & maintenance, technical files and design dossier writing, and regulatory and quality assurance compliance to a number of medical device requirements including; quality systems to ISO 13485 and 21 CFR 820, design controls to 21 CFR 820.30, the CMDR and MDD.
His background includes extensive experience in EMC and V&V testing, and the assessment and certification of medical devices for a wide-range of products including; surgical equipment, infusion pumps, and other patient-connected electro-mechanical medical devices. He has a strong background in product safety for medical electrical devices (IEC 60601 series of standards), CE marking for medical devices, and in the documentation required to support these requirements.
He has been a key member in various aspects of design and development projects, from the initial product design to full product commercialization, with an emphasis on daily interaction with R&D and the development teams.
Charles (Chuck) Sidebottom is a Senior Associate of Eisner Safety Consultants. Prior to his consulting career with Eisner Safety Consultants and PPO Standards, Chuck was Director of Corporate Standards at Medtronic. He is a Medtronic Technical Fellow, a Subject Matter Expert on standardization for the World Medical Device Organization (WMDO) and a registered professional engineer.
He has experience setting up corporate standards development programs, is a 60601 Series of Standards Interpretation Expert and is an expert on Medical Device Labeling & Symbology. He is heavily involved in standards work since 1987, Mr. Sidebottom serves as Secretary of the International Electrotechnical Commission (IEC) Subcommittee (SC) 62A, Common aspects of electrical equipment used in medical practice, Secretary of the International Standards Organization (ISO) Technical Committee (TC) 150/SC 5, Osteosynthesis and spinal devices, and is the Producer Vice-Chair of ASTM International Committee F04, Medical and Surgical Materials and Devices. He is also the Conveners of ISO 15223-1 & 15223-2 under ISO TC 210.
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.
John Abbott, Ph.D., provides consulting and training services on international standards, regulatory processes, ultrasound metrology and general engineering management. He works with international regulatory agencies, government officials and industry associations to promote the use of international standards and common processes in agency regulatory systems. Dr. Abbott regularly participates as invited speaker in international standards workshops and forums most including such organizations as the Joint Commission on Commerce & Trade (JCCT) and the Asian Harmonization Working Party (AHWP). Areas of expertise include risk, quality systems, medical device safety, regulatory processes, international government relations, negotiation, software as a medical device, standardization as well as engineering expertise in diagnostic ultrasound systems and transducers.
A dedicated advocate for international standardization since 1986, Dr. Abbott holds the chairmanship of the International Electrotechnical Commission (IEC) Technical Committee 87, Ultrasonics. He is also convenor of IEC Subcommittee 62B, Diagnostic Imaging Equipment, Maintenance Team 34, and is a US expert in IEC SC62A, IEC SC62B, ISO TC210, ISO TC215 and ISO TC245. Dr. Abbott is chairman of the USNC IEC TC87 technical advisory/mirror committee and has served on the USNC Council and Technical Management Committee since 2004. His hands-on experience in forums around the globe has enabled him to make tremendous contributions to the development & adoption of international standards while fostering medical device safety. In addition to his experience with standards, regulations and medical device safety, Dr. Abbott has extensive technical expertise in the engineering of diagnostic ultrasound imaging systems, ultrasound transducers and acoustic metrology.
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.
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