ESC EXPERTS & ASSOCIATES

Leo Eisner “(the IEC 60601 Guy)”

Leonard (Leo) Eisner, the “IEC 60601 Guy”, is founder and principal medical device product safety and regulatory consultant of Eisner Safety Consultants. Leo’s focus is on active medical electrical equipment (IEC 60601 series).  Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He is a registered professional engineer in safety, has over 35 years of experience in product safety, and over 30 years of medical device experience. 

He has certified and audited active / non-active medical devices, including active implantables and non-medical devices / components. His comprehensive knowledge enables Leo and his team to provide holistic guidance and support to clients on product safety; EMC; software life-cycle; risk management; labeling; regulatory and clinicla support; identification of applicable standards, laws, regulation & guidances, DHF & technical documentation; including training and more.

Leo is an expert in the standards development process staying at the forefront of evolving medical device standards; such as IEC 60601 series, ISO 15223, and ISO 20417. Leo ensures that your medical device compliance needs are met with uncompromising attention to detail and quality. Leo’s leadership and commitment in the standards development process runs deep and over many years including IEC 60601-1, 4th edition current development work & IEC 60601-1, edition 3.2, US co-chair of AAMI TAG 62D on electromedical equipment, US chair of AAMI EV-WG13 & IEC convener of IEC TC62 / SC 62D / JWG9 on Lens removal and vitrectomy equipment.

Leo has been involved in numerous IEC, ISO, and AAMI working groups, committees, and maintenance teams over the last 20 years. To see a more detailed list go to Leo’s LinkedIn Profile.

He routinely is a guest speaker for webinars and podcasts, and written many articles as an international expert on the topic of IEC 60601 series and standards development (Refer to blog for current articles, webinars & archive articles for older publications).

Leo is the manager of a LinkedIn Group – IEC 60601 Series – Medical Electrical Equipment

Bill Hardin

Bill Hardin has over 40 years of medical device R&D experience at Manager through Sr. Director levels with a special focus on systems engineering and compliance engineering at Siemens, Philips, General Electric, Boston Scientific, Carefusion and others. He has worked for large, medium, small and tiny firms and understands the different demands of each. He has developed capital medical equipment as well as single use sterile disposable devices.

Bill specializes in creating design input documentation packages, including user needs, use FMEA, hazards analysis, product requirements specifications, label requirements specifications, label design, and master verification/validation planning. He has significant program/project management experience and can organize a project as well as manage it through to product launch.

Bill is an expert at IEC standards for medical devices and teaches courses to designers on how to apply them. He is an expert at designing for safety, EMC, software life-cycle, usability, and labeling compliance, as well as design controls, quality systems, and regulatory requirements, and is adept at resolving safety/EMC test failures/issues. He also has significant experience in dealing with China, Brazil and Japan regulations and registration/testing issues.

Beat Keller

Beat Keller has 15 years of experience in medical device developmenth, has held several positions which highlights his broad knowledge of software development to risk management, verification and validation, quality management and regulatory affairs. Beat is a member of several standardization working groups in Switzerland, Europe (CENELEC), and internationally at IEC. He has worked in both the engineering service provider and medical device manufacturer environments. Beat Keller is a Swiss diploma Engineer in electrotechnics.

Lisa Donlon

Lisa, an experienced professional in life science regulatory affairs, boasts 25+ years of combined experience across clinical and regulatory fields. Her clinical background and medical device Notified Body experience have equipped her to handle a wide variety of devices, specializing in EU market access and clinical support. As a consultant, she collaborates with both medical device and pharmaceutical companies of all sizes, assisting clients in their interactions with regulatory bodies. Lisa provides valuable guidance on early-stage classification, regulatory pathway advice, and submission remediation.

An IRCA-accredited medical device principal auditor, Lisa is well-versed in working with standards such as ISO 13485:2016, ISO 9001:2015, MDSAP, 21 CFR Part 820, and the regulatory requirements outlined in 93/42 EEC and EU 745/2017 MDR. Despite the growing global complexity, Lisa remains committed to making quality and regulatory processes more understandable. She firmly believes that investing effort into clarity in documentation yields significant dividends.

Dan Modi

Dan Modi has over 35 years of experience in achieving medical device certification to standards. He has held positions from Lab Engineer (running the tests at a Lab) through Director (R&D) at Fortune 500 Medical Device company managing product compliance, design quality, and regulatory submissions. Dan’s expertise is in EMC, Product Safety (IEC 60601-1 seires standards), Risk Management (ISO 14971), Labeling (EU MDR, EN 20417, etc.) and Design Control (ISO 13485) compliance. He also has substantial regulatory experience with worldwide registrations for E.U, U.S, India, China, Brazil, Japan, etc. Dan teaches at University of California Irvine and has also taught product certification courses in the industry. Dan is an iNARTE Certified Product Safety Engineer & Certified EMC Engineer. Also, a Certified Regulatory Affairs Professional (U.S, E.U & Canada). He has also been involved in electrical safety and risk management standard development in the past. He was one of the founding members of the Product Safety Society at the IEEE, and has presented at numerous conferences.

Mike Wetherington

Mike Wetherington has an extensive career spanning over 30 years of medical device RA/QA, product safety certification engineer, and medical device engineering.

Mike’s diverse experience includes working with major accredited testing laboratories and notified bodies, certifying medical devices of all types, from non-active to active devices like joint compression devices, rapid infusion pumps and surgical saws. His expertise also extends to R&D companies in the medical device sector.

He has generously shared his knowledge as a mentor in Elemed’s Mentoring Program, helping RA/QA professionals reach their goals and enhance their leadership skills.

With a diverse experience spanning various regulatory markets, including US FDA 510k, CE marking under the MDR, UKCA marking, ASEAN Medical Device Directive, and more, he brings a wealth of knowledge to the realm of medical device regulation.

Rebecca K. Pine

Rebecca K. Pine has over 30+ 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.

Mark Roberts

Mark Roberts is a certified lead auditor (MDD, MDSAP, 13485), and CE marking and product sterilization expert. He has over 40 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.