Qserve Group Global Team
Willibrord Driessen (Founder)
Willibrord is Founder, President and CEO at Qserve Group BV, a global Medical Device Consulting company. Prior to founding Qserve®, Willibrord held a number of key senior management positions in the Medical Device Industry. He brings more than 20 years of senior management skills to the Qserve Group in the areas of Quality Management Systems and Regulatory Affairs. Willibrord’s particular fields of expertise are in the Project Management, Due Diligence & Strategic Planning, International Technical Documentation, Quality management systems ISO 13485, FDA QSR, Canadian CMDCAS, including Auditing (Lead Auditor) and Training on those subjects. Willibrord has extensive knowledge of CE Marking & 510(k), worldwide submissions strategies and International (clinical) strategic regulatory affairs.
Susan is Principal Consultant. Prior to holding this position, Susan was QA/RA Manager for a medical device company manufacturing Class III medical implants. She has held strong responsiblities for project management. Susan is very experienced in conducting literature studies, and technical writing and editing of medical-scientific-engineering documents. Susan is an advanced certified biological safety expert for medical devices. Susan has a broad scientific background holding Master’s degrees in both Biology and Geology, and Information Science and Technology. Susan is a native English speaker and is proficient in Dutch, German and French.
Peter Reijntjes, Drs.
Peter is a Principal consultant medical devices and trainer with extensive knowledge of and experience with Quality Management Systems and Technical Documentation implementation and compliance. Peter is very experienced project manager. He has worked 16 years for a renowned Certification and Notified Body, also as lead-auditor ISO 9001 and ISO 13485.
Martin is for more than 15 years experienced in Medical Devices and Pharmaceuticals. Martin has been part of the management team of a global Notified Body. In his position he was responsible for Business Development with multinationals, as well as start-ups, mainly with high risk devices (class IIb, II, AIMD). He is very experienced in global market access and is a recognized speaker at medical device conferences. He is specialized in regulatory strategies and planning, borderline devices, and cardiovascular and medical implants. Martin has a polymer chemistry background.
Patsy Trisler, JD, RAC
VP Regulatory & Clinical Affairs; Qserve US (office: Washington Area)
Patsy’s experience spans 26 years in regulatory affairs, starting with employment at the FDA’s Center for Devices and Radiological Health in 1985. She began consulting in 1991 and has owned her own consultancy firm since Oct 2003. Prior consulting and senior management positions were with biologics and medical device consulting firms and international clinical research organizations. Patsy advises medical device and combination products’ companies on a wide array of regulatory and clinical trial compliance issues. She consults on preclinical and clinical testing requirements; provides strategic guidance on regulatory pathway and clinical trial design; prepares regulatory submissions, including pre-IDEs, IDEs, RFDs, 510(k)s and PMAs; serves as clients’ liaison with the FDA; and performs due diligence assessments for financial firms. Her regulatory experience encompasses product categories in numerous therapeutic areas, including tissue/cell-based treatments; blood products/blood processing; brain surgery; dental/craniofacial/ oromandibular; drug/biologics delivery; general hospital; organ transplant; orthopedics; pain therapy; plastic surgery/ reconstructive/cosmetic; soft-tissue reinforcement; tissue sealants; urological; weight-loss; and wound care.
Fred Pet, BSc.
Principal Consultant
Fred is a Medical Device and a biotech executive with over 20 years of extensive industry experience. He developed, changed and managed regulatory and quality programs at different facilities both in Europe and Africa. Fred is an expert in the area of Medical Devices ranging from Class I through Class III as well as drug device combination products from development, validation, manufacturing, testing, labeling to distribution. Implemented, changed and maintained QMS systems at several manufacturing sites across the globe (France, Mauritius, Netherlands, United Kingdom) resulting into ISO 9001 and/or ISO 13485 certification and/or certification renewal. He is experienced in the interaction with regulatory bodies on product and process development issues and CE certificate transfer. Fred is a native Dutch speaker and fluent in English both verbal and in writing.
Senior Consultant
René is a senior consultant medical devices with extensive knowledge of and experience with Quality Management Systems & FDA QSR, Design Control, Risk Management, Packaging design and validation Electrical safety IEC 60601 and Electro Medical Compatibility. René is a very experienced project manager. He has more than 20 years of management skills.
Controller en ICT manager control.
Esmeralda started her career working for an accounting firm. Her responsibilities were auditing, preparing annual statements and various tax declarations for the clients.
She worked for more than 12 years for McDonald’s Netherlands and McDonald’s Corporation, as finance manager, franchise accounting controller and SOX implementation manager. As member of the international SOX-team she traveled to various countries in Asia, Latin America, Europe and America to assist with the implementation of the appropriate internal controls. She worked 6 years for different companies on Curacao (former Netherlands Antilles). Her last position was General manager of House of Solutions an accounting firm (back-office on Curacao) for customers in the Netherlands.
Associate Director Clinical Research
Lorraine has a university degree biology (physiology and marine ecology). She has extensive experience in all operational aspects of clinical studies, including international Project Management. Her experience includes clinical development of Medical Devices, medicinal and nutritional products. She is responsible for the operational clinical activities of Qserve, which include preparation, monitoring and evaluation.
Mason Diamond, DDS
VP Regulatory & Quality Affairs; Qserve US (office: NY Tri State Area)
Mason brings to Qserve over 25 years of medical industry experience, including 20 years spent as a Biotech Executive with extensive industry, academic, and clinical practice experience encompassing Medical Device, Pharmaceutical, and Biologics development. Mason developed and managed regulatory programs across many therapeutic areas, including, plastic and reconstructive surgery, dermatology, wound care, diagnostics, orthopedics, cardiovascular, etc. Mason is an expert in the area of combination product development (i.e., combined drug-delivery device products, drug-coated implantable medical devices, drug delivery systems, etc.). Mason’s wide range of expertise includes: Strategic regulatory planning, Global quality system development, CE Marking, 510K, PMA, IND , Pre IDE, New technology assessment and strategic planning.
Gert de Vries, BEng biomedical polytechnics
Consultant
Gert is consultant in medical devices regulations and standardization. He has worked senior biomedical equipment engineer in hospitals. Gert has long working experience in the health care industry as independent advisor for Quality Management Systems, regulation and standardisation. His fields of interest within Qserve are all aspects of medical devices with emphasis on Quality Management System compliance and regulatory affairs requirements. He specialises in electrical medical devices (Electrical Safety 60601 3rd edition) and medical software with particular interest in preparation of QMS, medical device risk management and technical documentation required for regulatory clearance. Holding a bachelor degree in polytechnics subject biomedical engineering. He also works in one of the university hospitals of Amsterdam as quality control engineer for physics and medical technology.
Paul van Geffen, PhD
Albert Koster, MSc, BSc
Consultant
Albert finished his Bachelors degree in mechanical engineering as a result of a thesis-internship at Nucletron B.V. in 1999. He started his working career as a designer in medical instruments for radiotherapy. As senior designer, Albert managed several product releases of medical devices. Also he studied to earn his Master of Science degree in Engineering and Product Design. After 6 years as a R&D designer, he started as a CAD/ CAM consultant teaching mechanical design applications. He re-entered the medical device industry by working as a product manager for Isodose Control. At Isodose Control he worked to realize an instrument portfolio for radiotherapy from scratch where he was strongly involved Technical Dossier compilations and International Regulatory Affairs within ISO 13485 Quality Management System. He released several instrument sets (re-useable & disposable) for the Medical Device market being the R&D product manager.
Leon Doorn, MSc
Consultant
Leon is experienced in working with medical devices as a nurse and looks at them from a patient perspective. After finishing his bachelor's degree as a nurse, conducting research in hospitals, he decided to get his master's degree in Health Sciences at the "Vrije Universiteit" in Amsterdam. During his masters Leon developed research skills conducting research as freelance consultant and during his intership at the Amsterdam municipal healthcare centre. During this intership he set up his own epidemiologic research within the Amsterdam "JUMP-IN" study. Prior to working for Qserve, Leon worked as a communications consultant for major pharmaceutical companies.
Jiske Simons
Consultant/Sr. Clinical Research Associate
Before starting at Qserve, Jiske has worked for more than seven years as (Sr.) Clinical Research Associate at the Clinical Research department of several pharmaceutical companies in the Netherlands. She is very experienced in managing registration studies and post-marketing trials.
Jiske has developed strong collaborative multifunctional communication skills. Besides working at Qserve, she owns her own company ‘JS|Solutions’ for interim and project management projects within the pharmaceutical and healthcare industry
Kitty is junior consultant in medical devices regulations and standardization. She is specializing in technical writing and editing of medical electrical equipment compliance documents for basic safety and essential performance including literature studies. Kitty studied Biomedical Engineering and graduated in the Biomedical Optics research group at Twente University, in collaboration with a local hospital. Furthermore she conducted research at NIVEL research institute to identify common (organizational) limitations regarding the usage of medical devices in Dutch hospitals, compromising patient safety.
Tanja Hennis, BSc
International Human Resources
Tanja is responsible for Human Resources within the Qserve Group since 1998. She earned her degree as dietician. Tanja is working in the field of Health Care for more than 25 years.
Consultant Quality and Regulatory Affairs; Qserve US (office: New England Area)
Junior Consultant Quality and Regulatory Affairs; Qserve US. (Greater Cambridge/Boston area)
Parth is a junior consultant for Quality and Regulatory Affairs with Qserve America Inc. He has graduated from Northeastern University, Boston with MS in Regulatory Affairs for Drugs, Biologics and Medical devices. Parth provides expert advise on Regulatory submissions and strategies for medical device companies. He prepares regulatory submissions such as 510(k), PMA, Pre-IDE, IDE, HUD, 513(g), establishment registration and device listing. Parth has a wide variety of experience with class II devices. He has previous experience with regulatory submissions for drugs – Pre-IND, IND, NDA, Orphan drug designation and also for Biologics – BLA.
Stephanie (Xing) Huang, Mcom
In Country Representative / Regulatory Affairs; Qserve China
Stephanie conducts research and works on consulting projects in Asian area. She is also responsible for developing business opportunities, strengthening client relationships and promoting company’s image. Graduated with MCom from University of Sydney, she has spent time studying and working in China, UK, and Australia. Prior to joining Qserve, she has been part of the management team of a British clinical research organization (CRO) based in China. She has managed various projects successfully, promoted pharmaceutical products and medical products, and targeted the suitable partners for both western and eastern clients. By leveraging company’s strengths, she helped company extend services and technology capabilities in support of clinical research across all phases of development. She is familiar with local pharmaceutical and medical device enterprises, government regulations, and industry environment. With an insight of operation, procedure, and culture in both Asian and western companies, she brings organization greater effectiveness and benefits.
Stephanie is a native Chinese speaker and exellent English speaker.
Financial / Controller (advisor)
Adri was trained as a Register Accountant and was in senior financial positions including audit manager at one of the big four audit firms and Vice President Finance – Europe for a large biotech pharmaceutical company. After that, Adri held positions as Managing Director of a manufacturing facility of high-risk implantable medical devices and as President of a French Group specialized in Urology products. Adri also held positions as Chairman of the Board of Supervisory Directors in a fully qualified GMP approved test laboratory company and as Vice President of IAPM, a trade association of implant manufacturers until it merged with Eucomed.
Over the past few years Adri has returned to his roots taking mostly interim and freelance financials positions for service providers to the pharmaceutical and medical device industry. Adri is a member of the Board of Supervisory Directors (RvC) of a local bank.