Qserve Team, The Netherlands (Headquarters)
Willibrord Driessen, President & CEO, Qserve Group
Susan Klymowsky, Drs., Principle Consultant, Qserve Consultancy
Peter Reijntjes, Drs. , Senior Consultant, Qserve Consultancy
Jan Winters, Ir, Consultant, Qserve Consultancy
Gert de Vries, B.Eng, Consultant, Qserve Support
Albert Koster, MSc, BSc, Consultant, Qserve Consultancy
Paul van Geffen, PhD, Consultant, Qserve Consultancy and Qserve Support
Chris van Groeningen, PhD, Consultant, Qserve Consultancy
Leon Doorn, MSc, Consultant, Qserve Consultancy
Eric Hoorn, Office Management, Qserve Consultancy, contact: office@qservegroup.com
Tanja Hennis, MSc, Financ & HR Qserve Consultancy
Johan Bender MSc, PharmD, Consultant, Qserve Consultancy
Lotte Plantinga, PhD, Consultant, Qserve Consultancy
Qserve Team, America
Bill Greenrose, MA MBA , President Qserve America
Debra Ferland, Consultant & Office Management, Qserve America
Rhonda McFarland, Senior Consultant, Qserve America
Carlos Bullock, Consultant, Qserve America
Qserve Team, Germany
Arjan Stok, General Manager
Advisors
Max Rogmans, MD, advisor Business Development and new projects
Ad Sitsen MD PhD FFPM, Advisor
Qserve, in country representatives
Qserve United Kingdom
Jim Mackenzie MSc., MCQI CQP, MBCS CITP
Qserve France
Julian Itzcovitz Ph.D.
Qserve Group Global Team
Willibrord Driessen
President and CEO, Qserve Group
President & CEO of Qserve Consultancy and the Qserve Group, Willibrord has held a number of key management positions in the Medical Device Industry. He brings more than 25 years of senior management skills to the Qserve Group in the areas of Quality Management Systems and Regulatory Affairs. Willibrord is a qualified Lead Auditor holding Notified Body certification and CMDCAS certification Willibrord’s particular fields of expertise are in the implementation and management of quality management systems ISO 13485:2003, CMDCAS, ISO 9001 and auditing. Willibrord has extensive knowledge of international regulatory affairs, and has specialist knowledge of CE Marking. He is also an experienced coach of senior managers and is a qualified trainer in all aspects of quality management systems, auditing, and regulatory affairs.
Bill Greenrose,MBA BA,
President, Qserve America Inc.
Bill brings to Qserve over 25 years of medical industry experience, including 13 years spent as a senior manager. Bill’s wide range of expertise includes: Strategic regulatory planning, Global quality system development, CE Marking, New technology assessment, Business development and Medicare reimbursement. Having served at various times as C.F.O, C.O.O, V.P. Operations, General Manager Sales and Marketing, and as a Director and Corporate Secretary, he has acquired a unique understanding of both the needs and the contributions of the various departments and disciplines within an organization and how they interact at all levels to achieve a common corporate goal.
Arjan brings to Qserve over 20 years of medical (Dental) industry experience, including 13 years spent as a senior QA & RA manager. Arjan’s wide range of expertise includes: Global Quality system development (ISO 9001, ISO 13485, PAL/JGMP, CMDCAS/ FDA Quality System regulations (QSR)), CE Marking, Product submission, Process validation, Risk management ISO 14791 and Environment compliance ISO 14001. Having served at various times as QA manager, Environment Manager, Head of the Documentation division (Medical), Arjan is also an experienced coach of senior managers and is a qualified trainer in all aspects of Quality & Regulatory management. Arjan speaks fluently German (native), Dutch (native) and English. Arjan is a qualified Lead Auditor holding a Notified Body certification.
Susan Klymowsky, Drs.
Principle Consultant
Susan is Principle Consultant. Prior to holding this position, Susan was QA/RA Manager for a medical device company manufacturing Class III medical implants. She 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.
Senior Consultant
Peter is a senior consultant medical devices and trainer with extensive knowledge of and experience with Quality Management Systems and Technical Documentation implementation and compliance. He has worked 16 years for a renowned Certification and Notified Body, also as lead-auditor ISO 9001 and ISO 13485.
Jan Winters, Ir.
Consultant
Before starting consultancy at Qserve, Jan worked for several companies in the optical, electronic, medical device and pharmaceutical industry with strong responsiblity for project management, Quality Systems (ISO 9001, ISO 13485, QSR and CMDCAS), Auditing (supplier and Internal' and Procurement. Jan has worked with J&J (Cordis), Philips Medical, and Medtronic.
Gert de Vries, B.Eng.
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 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.
Chris van Groeningen, PhD
Consultant
Chris van Groeningen is a consultant. Chris holds a PhD in Human Physics (Utrecht University) and hold a Masters in Biology. He has worked over 10 years as a Researcher and a Scientist in the Medical Device industry (Vitatron, Medtronic) and holds experience in research studies, clinical studies, device therapies, diagnostics and advisory systems. In his last position as Senior Scientist at Medtronic he was responsible, amongst other things, for developing new clinical applications for the implantable cardiac monitor.
Paul van Geffen, PhD
Albert Koster, MSc
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 13845 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, BSc
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.
Tanja Hennis, Msc
Finance & Human Resources
Tanja is responsible for Human Resources and Finance 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.
Johan Bender Msc Senior Advisor, MSc, PharmD
Johan has 15 years experience in Pharmaceutical and Medical Device Industry. He has been for many years partner and Managing Director of Bactimm BV and Farmalyse BV, a contract Microbial & Chemical Research laboratory. His expertise spans QP activities to high risk combination Medical Devices He is an expert on Drug Master Files, Chemical/Pharmaceutical & Manufacturing parts of Drug applications, ISO 10993 (part 1, 7, 9, 13, 14, 17 and 18), shelf life & sterility studies. In addition to working with QServe Group BV, Dr. Bender manages his own Development & IP company focusing on Biomaterial implants, drug development, drug delivery, consulting firm serving Drug, Medical Device and IVD clients worldwide.
Max Rogmans, MD
Advisor
Max Rogmans is a consultant specializing in Technology Transfer and Business Development. Originally trained as Physician, he worked two years at the Surgical Department of the Academic Hospital, Free University, Amsterdam.
Ad Sitsen MD PhD FFPM
Advisor
Ad is a senior advisor in Clinical Developments of Pharmacology. Ad earned his degrees in physics, Pharmacology and Medicine. Ad has been working at senior functions such as Medical advisor, Head of the section CNS DRUGS, Organon.
Jim Mackenzie MSc., MCQI CQP, MBCS CITP
Associate Consultant UK
Jim is located in United Kingdom. Jim brings to Qserve over 25 years of Medical industry experience. He is Quality Consultant, Medical Devices & IVD Lead Auditor. A highly experienced Medical Devices and In Vitro Diagnostics manufacturing and quality / regulatory professional having implemented Food and Drug Administration Part 820, ISO 9001 & ISO 13485 Quality Management Systems Worldwide and developed and presented Quality Management System training programmes on Medical Devices and In Vitro Diagnostics at all levels within multi national organisations.
Julian Itzcovitz Ph.D.
Associate Consultant France
Julian is located in France, Julian experience is now more than 20 years with the medical devices and biotech markets, keeping various management positions such as R&D, Clinical Research, Business Development and Marketing. He brings to Qserve the following knowledge and expertise: - more than 20 years of experience with the medical devices market, particularly related to: multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal microscopy and fluoroscopy imaging, image guided minimally invasive procedures for cardio-vascular and oncology applications: digital –x ray stenting and angioplasty.