25 years of sharing global knowledge
5th Qserve MedTech Conference 2023 | Achieving Full Compliance
Following the success of Qserve’s previous conferences and events, we extend an invitation to join us at the 5th International Qserve MedTech Conference, where a very diverse program will be presented by Qserve’s internal hosts and with speakers from the industry, Notified Bodies, and Competent Authorities.
25 years of sharing global knowledge
Qserve Group Speakers
Gert W. Bos, PhD, Fraps
Executive Director, Partner and Leading MDR-Expert
Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.
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Software and AI Expert
Coenraad is a Senior Consultant Software and Artificial Intelligence with over 20 years of experience in software development of which over 10 years in setting-up, maintaining and improving Quality Management Systems (QMS).
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Head of IVD
Sue leads Qserve’s IVD service, is EU Regulatory and Quality Expert including CDx and Lead Auditor. She has over 30 years’ of experience in the Medical Device and IVD industries including extensive notified body experience.
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Head of Clinical Services
Bianca has more than 15 years of experience in the medical devices field, ten of which have been spent at two major Notified Bodies, DEKRA and BSI.
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Since 2021 Esther has joined the Qserve Group as a consultant where she works as a medical writer for clinical evaluations.
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Giovanni Di Rienzo
Over 20 years of experience in the medical devices field (R&D, Notified Bodies, RA/QA consultancy). Giovanni has been working on MDR assessments, strategy and remediation projects since publication, gaining wide experience from both the manufacturer and the Notified Body sides. He has recently focused on monitoring the evolution of the MD regulation in the UK and on supporting clients to prepare for this new challenge.
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Head of Global Registrations
Daniëlle has been collaborating with local partners to support Qserve clients with their medical device registrations in EMEA, LATAM and APAC countries.
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Quality Assurance & Auditing Expert
Henk-Willem has over 15 years of experience in setting up, maintaining, improving and auditing Business and Quality Management Systems (QMS) based on ISO 9001, ISO 13485, MDD / MDR, MDSAP, and FDA 21 CFR 820 QSR.
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Quality & Regulatory Expert
Olena is a qualified medical device Lead Auditor who conducted over 100 regulatory audits against ISO 13485 as a Conformity Assessment Body auditor and MDSAP, MDD, and MDR (internal and suppliers) audits for Qserve clients.
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US Regulatory Affairs Expert
Lorry is part of the US Regulatory Affairs team and IVD team, her area of expertise is US FDA, 510(k) submission and European Medical Device legislation.
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Clinical Project Manager
Armêl Plaine is an experienced professional of over 14 years in clinical investigations with medical devices. Armêl combines hands-on experience in clinical operation including start-up activities and comprehensive knowledge of clinical investigation.
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Jorn van Binsbergen
Since October 2021 Jorn van Binsbergen has joined the Qserve Group as clinical writer where he works within the Qserve CRO team.
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UDI & Regulatory Affairs Expert
Agnieszka’s main expertise is in Unique Device Identification and GS1 standards, both in labelling requirements, data publication and maintenance of UDI records as well as procedural alignment. Since joining Qserve, she has successfully undertaken over 40 projects associated with UDI obligations across several markets, with focus on the EU and the US.
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IVD, Regulatory Affairs and Clinical Affairs Expert
Natalie has extensive experience with regulatory and clinical affairs working with in vitro diagnostics. She develops regulatory strategies, and prepares US 510(k) and de novo submissions and IVDR tech files. Her expertise is IVD clinical studies – Natalie is well-versed in the preparation of clinical studies to ensure they are conducted per Good Clinical Practice and may be used to support subsequent regulatory submissions.
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IVD Product Development Expert
Kristiane has over 15 years of experience with product development in the IVD industry, ranging from proof-of-concept research to verification/validation and implementation of product development under ISO 13485. She has hands-on experience with different technology platforms such as qPCR, immunoassays and point-of-care devices. At Qserve, Kristiane’s focus areas are IVD product development, PMS and PMPF and generation of technical documentation for CE-marking.
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IVD/CDx design, validation & regulatory submissions
Jude has over fifteen years of experience in the IVD industry, specializing in the development, validation, and regulatory approval of clinical trial and companion diagnostic (CDx) assays.
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Regulatory Affairs Associate
At Qserve, Dennis has supported various customers with market registrations and market access strategies on a global level acting from within Qserve’s Global Registrations Team. In addition, he worked for several customers on Post-Market Surveillance and electronic Quality Management System projects.
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Regulatory Affairs & Quality Assurance Expert
At Qserve, Robert has worked for several customers as Quality and Regulatory Officer, supporting them with and/or creating Clinical Evaluations, Quality Management System remediation projects, CAPA management, risk management, postmarket surveillance plans, responding to Notified Bodies on any non-conformities found during audits, conducting and supporting audits, training on ISO13485, MDSAP and MDR.
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VP Regulatory Compliance US
Keith is responsible for technical consulting, as well as business development and sales. Keith has experience and competence with an extensive range of devices (Wound care, Vascular, (active) implants, combination devices, IVUS).
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Quality and Auditing Expert
René brings more than 20 years of management skills to Qserve in the areas of Quality Management, Research & Development, Custom made medical devices, Contract Manufacturing, Business Process Reengineering, Configuration Management and Information Technology. As (lead)-auditor he has regularly conducted ISO 9001, ISO 13485 and MDSAP audits, both internal and at suppliers.
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Stéphane has in-depth knowledge of European regulatory and biocompatibility requirements for non-active, single-use and implantable medical devices. During his 20+ years of experience, he spent ten years as R&D engineer in an orthopedics company and two years at a major Notified Body (TÜV SÜD). In other companies, he supported the development and the documentation of different products such as sterilizers, spine implants and ablation lasers.
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25 years of sharing global knowledge
Clinical Expert and Product Reviewer at Kiwa Dare Medical Certifications
As an expert within Notified Body Kiwa Dare since 2012, Natascha Cuper conducts technical and clinical reviews of medical devices in the field of active devices. She studied Veterinary Sciences and holds a PhD in the field of human Medicine. She has played a large role in obtaining designation of DARE as a Notified Body, under the Medical Device Directive and Medical Device Regulation.
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Stan Geurts, M.D.
CEO De Hulpdokter
De Hulpdokter is a trusted provider of medical translations in any language and supports companies in writing medical texts at the appropriate reading level. Join this session to learn how comprehensible medical texts lead to better user safety and more favourable patient outcomes. You will gather useful tips and tricks that are directly applicable to any medical text.
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