Senior Faculty Board

Sharing Expertise

Senior Faculty Board (SFBs) play a vital role throughout the WMDO educational development process. By sharing their extraordinary insight, expertise and knowledge in medical device regulatory, pre-clinical, clinical, marketing and reimbursement subject areas, ranging from entry level basics to high level strategies, they provide the critical content that constitutes the core of WMDO educational resources and online courseware.

Arthur Brandwood

Managing Director, Brandwood Biomedical

Senior Faculty Board BSc, PhD, MIMMM, CEng, AIMM Managing Director, Brandwood Biomedical, Australia   Arthur Brandwood has over 25 years experience in the medical technology field in industry, academia and government. He has lived and worked in Europe, Australia and South East Asia. Combined with his senior...Full profile

Barry Sands

RQMIS Inc.

Barry is a biomedical engineer with a chemical engineering concentration. He is president/founder of RQMIS Inc. a consulting company with experience in the Medical Device/Biotechnology Industry focused on Regulatory/Clinical/Quality Affairs and Product Management. RQMIS Inc. provides support in the areas of regulatory submissions (510k, IDE, PMA, HUD/HDE, Design Dossiers), Clinical Study Design/Management, Risk Management, Quality System Design/Audits (FDA QSR and ISO 13485) and FDA Negotiati...Full profile

Carla Monacelli

Argenta Advisors

Managing Partner, Argenta Advisors™ Carla has worked in the field of reimbursement, healthcare policy, and government relations for over 18 years. In 2001, she co-founded Argenta Reimbursement Advisors (formerly Certus Healthcare), and in 2007 co-founded Argenta TEC Advisors. Prior to establishing Argenta, her career experience included lobbying for at a top Minnesota law firm and payer relations and reimbursement strategy for multiple clients at a large Washingt...Full profile

Christian Vander Velde

Senior Faculty Board SALES & MARKETING, ADVISOR PhD, MBA   Christian Vander Velde has more than 30 years experience in the European Medical Device Industry, having held positions in Research & Development, Strategic Planning, Sales Management, International Marketing and Market Access, with both multi-national companies (Boston Scientific,...Full profile

Danielle Giroud

Founder, WMDO & MD-CLINICALS

With over 25 years of experience, Ms. Giroud is founder and senior faculty board member of the World Medical Device Organization (WMDO), an independent professional organization dedicated exclusively to serving the professional development and educational needs of medical device professionals from around the world. Since 2013, Mrs Giroud also founded MD-CLINICALS, a 100% medical device dedicated Clinical Research Organisation with main activities in the Asia Pacific, South American, E...Full profile

Graham Stokoe

Consultant, GPS Consulting

Senior Faculty Board HEALTH TECHNOLOGY Graham Stokoe has more than 25 years experience in the European Medical Device industry. With broad experience in European sales/marketing, general management and more recently Public Policy, Health Economics and Reimbursement, Graham is now an independent consultant with affiliations to a number of organizations specializing in market acce...Full profile

Greg Sachs

Sachs & Associates, Inc.

Greg Sachs is Founder and President of Sachs & Associates, Inc., specializing in U.S. and international regulatory/clinical affairs, quality assurance and product development.   With over 25 years of experience in the medical device industry, Mr. Sachs has held a variety of high-level functions including Director of Regulatory Affairs, Vice President, Regulatory, Clinical, Quality Assurance, Operations and Executive Vice President and has been extensively involved thr...Full profile

Jan Van Lochem

Jan van Lochem holds masters degrees in biomedical materials and business marketing. Starting his career in R&D on PTCA catheters, he entered the regulatory field as auditor and technical product specialist for cardiovascular devices at a European Notified Body in 1996. From 2000 to 2003 he worked in the United States to build a Notified Body presence. As Head of Notified Body and regulatory specialist in the European Medical Device Directives, he has been involved fro...Full profile

Jean-Pierre Boutrand

General Manager, Biomatech

Senior Faculty Board PRE - CLINICAL After joining Biomatech/Namsa in 1996, Dr. Jean-Pierre Boutrand has served as a Study Director, Department Head and Pathologist, Director of Operations. He currently serves as General Manager and Scientific Director for Biomatech/Namsa. Prior to joining Biomatech/Namsa he was involved in research and teaching functions in the academy. Dr. Boutrand recei...Full profile

Lee Leichter

President, P/L Biomedical

Senior Faculty Board Lee Leichter has over 35 years' experience in the health care industry. He has been providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 15 years. Projects have encompassed a multitude of business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe a...Full profile

Marcelo Antunes

SQR Consulting

With more than 10 years of experience in medical device consulting, Marcelo is the CEO of SQR Consulting, which specializes in areas of expertise such as risk management (ISO 14971), quality systems (ISO 13485, GMP), regulatory systems (CE mark, ANVISA) and testing and standardization (IEC 60601 series).  Marcelo is also a professor of Medical Device Design and Development at the Biomedical Engineering Department of the Pontificia Universidade Catolica de São Paulo as well...Full profile

Martin de Bruin

Senior Faculty Board   Martin de Bruin (MBA, Drs.) joined the Notified Body KEMA Quality in 2000. Since 2009, the Notified Body exists of The KEMA Quality entity, CE 0344, and the DEKRA entity CE 0124.  He and the team built the Notified Body to a full service provider for the medical device testing, and certification. Mr. de Bruin worked 5 years in the pharma industry before joining KEMA. He has 12 years experience in the Notified Body, as project manager, regional ...Full profile