Expert in deployment of lifecycle management system into Medical Device/Automotive vendors who seeking warranting successful Medical Device Development while maintaining Auditing and Regulatory Compliance through Process Automation Tools such as Orcanos ALM & QMS system.
It is no secret that Medical Device companies incur much costs and organizational stress relating to creating and maintaining their Technical File, DHF or ISO documentation or ASPICE compliancy, especially before first-time submission or external auditing by notified bodies.
Product quality through application development, database delivery management, and project manager in a wide variety of business applications. Particularly interested in software delivery processes and methodology such as Agile Scrum. Expert in the field of ALM application lifecycle management.
Specialties: Knowledge in the field of hardware, software, mechanical delivery and overall quality assurance. Knowledge in configuration management, testing, automation, development. Expert in building e-DHR system for small and medium business on an electronic platform.
Working with clients of tier 1 such as J&J, Medtronic, Siemens, Flex, Zimmer, CERN, aerospace, and defense as well government and other diverse industries.
LinkedIn Group manager of two important topics 21 CFR Part 11 and ALM. Acting as a personal trainer in Unistream organization developing next generation of junior entrepreneur during the high school period. Acting as Orcanos ALM/QMS/Manufacturing blog manager.
Sebastian Clerkin, Ph.D., B.Sc., is the Founder of GMP Advisory Services Ltd. and has more than 10 years experience in laboratory, pharmaceutical and medical device manufacturing environments. He currently provides validation and regulatory expertise to the Medical Device Industry. He has direct experience across a broad range of medical device types and process technologies. He has a keen understanding of FDA regulatory requirements, and has a strong background in process development, design transfer and validation.
Sebastian has published articles in peer-reviewed journals on topics such as cleaning validation.
He has a PhD from the University of Bristol, which involved studying the toxicological and biological effects of prosthetic implants. He holds a B.Sc. in Biochemistry from University College Dublin, and is a member of AAMI and ASTM.
Over 20 years experience in the Medical Device and Combination Device industry, principally in the area of Engineering Management but more recently in the rollout of manufacturing execution systems.
A Broad knowledge of medical device products , the customers that use them, the regulatory guidelines that control them and the supply and manufacture of those products. Also experienced in dealing with supplier aspects of the medical device business.
Valerio is currently managing the solution of transforming manufacturing environments to integrate new manufacturing technologies, data, computational power, connectivity, analytics and intelligence, human-machine interaction and advanced robotics, together with operational excellence approaches.
He is a professional with more than 20 years international experience. He started as consultant in the manufacturing industry, leading the implementation of improvement projects in several customers in Spain, Italy, France, Germany and Denmark.
He has consulted more than 60 companies along his career mainly in the Automotive, ASD, FMCG, Food & Beverage & Pharma industry. Main areas of expertise provided during these projects include Supply Chain Management, Design of Organization & Corporate Transformation (both in the design and implementation).
Before founding Activoris in 2015, Axel gained over 18 years of life science industry experience. He had roles with increasing responsibility in iv-Diagnostics, Lab Software, MedTech and Pharma.
In his last position at Activaero GmbH, Axel was Managing Director, COO. In this role, Axel was responsible for production, logistics, alliance management, QM and IT. Axel established multiple licensing and collaboration partnerships with biotech and pharma. He carries extensive knowledge about sourcing, technology partnerships and contract management in the life science industry.
Before joining Activaero, Axel spent one year as a Sales & Marketing Manager at Intellitec GmbH. Axel started his professional career at Siemens HealthCare Diagnostics as a Software Project Manager withtin the European Marketing Organization.
Axel holds a degree in business administration/marketing by the Fulda University of Applied Sciences.
Ana González is currently Project Leader at EPIC (European Photonics Industry Consortium). Her expertise relies on the development of systems based on integrated photonic circuits, packaging and assembly, and the investigation of applications such as chemical/biological sensing and Datacom. In addition, she has been involved in technology transfer and business development processes. She received her Bachelor’s degree in Chemistry from the University Autonomous of Barcelona (UAB) and her PhD degree from the Catalan Institute of Nanoscience and Nanotechnology (ICN2).
Stephanie Grassmann established MedTechXperts GmbH and is the managing director. She obtained a Bachelor of Science in Mechanical Engineering from the UofS and a Master of Science in Biomedical Engineering from the UofC in Canada. Since 1990 working in start-ups to multi-national companies including 2 universities, Stephanie Grassmann has been actively involved in different roles as an international manager in RA and QM, a developer and a researcher in the medical area and technical industry. She has a detailed understanding of international market approval processes, obtained through various RA positions and through the examination and the compilation of medical device technical files (all risk classifications) in the areas of orthopedics, trauma, navigational surgery, wound healing, cardiology, and dental medicine. In addition, she has lead, developed, and was responsible for new or improvements to existing medtech products (implants, instruments, devices), according to the international, EU harmonised, regional, medical field and product specific standards and regulatory requirements. Working at the University of Calgary, at the Orthopedics Department of the Foothills Hospital in Calgary and at the Universität Bern and as well as being the author of clinical publications and clinical evaluations over 25 years, has lead to a wide breadth of clinical knowledge.
Andrew Koubatis is Director of Medtech at Altran Switzerland . He studied Mechanical Engineering at McGill University and has an MBA in Management of Technology from École Polytechnique Fédérale de Lausanne. With more than 30 years of experience, he has worked on the development and integration of a broad range of technologies within the aerospace, life science, energy, industrial and consumer products industries. He is currently specializing in Medical Devices and innovation projects. In addition to his expertise with medical devices, he has worked with major pharmaceutical companies in the development of new combination products
Unmeshhas 10 years of healthcare industry expertise, comprising of strategy consulting, primarily with global pharmaceutical companies. His particular expertise lies in Market opportunity assessment, portfolio, brand, growth and go-to-market strategy.
His industry expertise lies among life sciences engagements across various therapeutic areas, leveraging relationships with key opinion leaders in sectors such as Global Pharmaceutical & Biologics Contract Outsourcing, API manufacturing in India & China, European Oncology & Diabetes market prognosis & Pharma sales force effectiveness.
In a previous role at IMS Health Consulting Group, Unmesh led a resource optimization engagement with a leading generic pharma company involving market sizing, structuring, customer coverage, frequency and channel optimization. At Novartis, he provided high complexity sales force and marketing analytics, enabling strategic decision making for internal customers and at UfM Health System, contributed to statistical analysis for leading nursing publications. Unmesh holds a MSE (Biomedical Engineering) University of Michigan-Ann Arbor, MI, USA.
Bernd Maisenhölder joined Iftest in 2016 as Director Marketing. In his role, he serves the company in both strategic as well as operational marketing. An important part of his assignment is to identify and develop new, emerging applications and customer segments particularly in the medtech field. Prior to working at Iftest, he had global responsibility for the Consumables Business at Tecan, Switzerland, driving innovation and product development as well as commercialization for Life Science Research, Diagnostics and Applied market segments.
Bernd graduated from the University of Konstanz, Germany, in 1993 with a masters degree in Physics. He then joined the Paul-Scherrer Institute Zurich, the former RCA research lab in Europe, to do a PhD in Integrated Optics for biosensing applications together with Ciba-Geigy and Balzers. From 1997 to 2004, he worked at Balzers in the field of optical biochips for protein and gene arrays in close collaboration with Novartis, Basel.
Gerald (Ger) Manley is a medical device professional with 20 years’ industry experience. Ger founded G&C Creations ltd in 2004 and to complement the consultancy division of the business, added contract technical services in 2009. G&C Creations is based out of Ireland and provides consultancy services across Europe and North America.
16 of the 20 years’ experience are in the medical device field working for a host of different companies with considerable market share in the diagnostics, instruments, consumables, packaging and orthopedics sector. Ger has extensive experience in New product introduction, technical transfers, product launches, process improvement, Lean, end to end supply chain and outsourced manufacturing. He has worked and consulted in all aspect of the medical device field and provides extensive consultancy on validation, design controls and all aspects of Quality systems.
National Cert. Electronics Engineering- Tralee Institute of technology Ireland.
National Diploma Mechanical and Electronic engineering - Tralee Institute of technology Ireland.
Bachelor of Engineering Hons Mechanical / Production Engineering - University of Limerick Ireland.
Thor S. Rollins, B.S.,RM (NRCM)
Director, Toxicology and E&L Consulting
Thor Rollins is a certified microbiologistand specializes inthe selection and conduct of invitroand invivobiocompatibility tests. Heactively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in2013and has many published articles on biocompatibility topics.
He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI)TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussingbiocompatibility methodsand voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients forchanges in testing.
AREAS OF EXPERTISE
- Biocompatibility –ISO 10993 in vivo& in vitrostudiesStudy design and test selection, justifications, product and regulatory considerations
- Material Characterization –ISO 10993 analytical studiesStudy design and test selection, justifications, product and regulatory considerations
- Medical DevicesClass I, II and IIIdevices including orthopedic, cardiovascular, pulmonary, disposables
- US FDA 510(k), EU and international medical device submissionsRegulatory test design and justifications, test requirements for biocompatibility
Fabien focuses particularly on guiding clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data), conformity assessment and registration procedures (e.g. preparation and review of Technical Files, preparation and review of responses to the competent authorities' and Notified Bodies' requests) and post-market activities (e.g. adverse event reporting, Field Safety Corrective Actions and promotional and advertising of medical devices).Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device Clients. Fabien also assists Life Sciences Clients in the preparation, drafting and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.
Jared Sebhatu is the Program Director,Germany for the German Accelerator Life Sciences. He is responsible for engaging life science startups and young companies and liaising with strategic partners. Having worked for numerous international companies,Jared is an expert in the German healthcare market and has extensive experience in the digital health and medical technology innovation process. He is currently mentoring various startups in strategy, technology,and innovation management.
The German Accelerator Life Sciences (GALS) is an initiative of the German Federal Ministry for Economic Affairs and Energy, with the goal of helping German startups and young companies succeed in the global marketplace. GALS offers support in multiple areas, from free office space in the world’s leading life science innovation hub, to mentoring and advising from industry experts and experienced leaders. GALS opened its doors in October 2015 and has its headquarters in Cambridge, Massachusetts. GALS helps create globally visible success stories for German life science startups and emerging companies.
Patrice Slupowski is Vice-President Digital Innovation running the open-innovation corporate product marketing team of Orange, in charge of several projects around APIs, Internet of Things, mobile applications & mobile OS, personal data aggregation, privacy or emerging technologies (AI, VR, …).
Patrice Slupowski is a marketing expert in IoT, social networks, connected TV, wellness & personal data and mobile multimedia services. He founded a start-up called Waptoo in 1999, one of the first companies to believe in the opportunities around mobile data, creating WAP and mobile services and proposing some automated mobile testing software, for companies and telcos, which has been acquired by Lagardere Group.
Patrice has been involved in digital space from the very first minute, and is permanently connected from 1990. Patrice is a graduate in Information Science and Technology from Paris-Dauphine University.
Patrick von Meiss obtained a degree in micro-technical engineering from the Ecole Polytechnique Fédérale de Lausanne (Federal Institute of Technology of Lausanne) in 1988. He then completed his studies with an MBA in 1992.
With more than 30 years of experience in machine tools and the medical equipment industry, Mr von Meiss gained critical knowledge in various segments such as dental, orthopedics, drug delivery and active implants. His various positions as Head of departments counting from 5 to 100 collaborators allowed him to get acquainted with all stages and processes from R&D, to manufacturing and customer advice.
His deep knowledge of all technologies, processes and challenges related to the manufacturing of innovative miniaturized implants is another string to his bow that he is looking forward to share during his presentation at Medtech Europe 2018.
Matthias Wufka is working for Zühlke Engineering as a Business Solution Manager. In this role he is responsible for a project portfolio in the sector MedTech, Pharma and Lab Equipement in southern Germany. He started his career in a company for intensive care equipment. He supported and guided many medical device projects in different roles (Developer, Quality Manager, Project Manager). In addition to the development of medical products he was one of the lead contributors for the new Zühlke medical development process. One of his specific interests is the incorporation of modern agile methods into medical development processes.