Cyrille Michaud, Managing partner at MD101 Consulting →
• Cybersecurity: How to deal with it throughout the Medical Device lifecycle?
Sofia Segersson, Owner, Consultant, Entrepeneur at Diabetesia →
• Medical Devices as Part of Your Daily Life – the User Perspective
Christoffer Ekström, CEO at AI Medical Technology →
• From user need to product specification – real world example
Åse Ek, Senior Consultant and Trainer at Key2Compliance →
• Being the ‘Person Responsible for Regulatory Compliance’ –is this in fact a quality control, regulatory affairs, or both?
Josef Smeds, Managing Director at NordicInfu Care →
• How the industry work to meet both user needs, and expectations from the buyers
Jocelyn Åkerberg at Stille AB →
• How Legal manufacturers shall control Contract manufacturers – the NB perspective
Magnus Tägil, MD, PhD and Professor
at Skåne University Hospital →
• How can device manufacturers meet user needs? Reflections from a healthcare perspective
Antti Virtanen, Solution Architect at Innokas Medical →
• Design transfer and contract manufacturing of medical devices – Practical tips and examples to mutually working relationship between customer and contract manufacturer
Judith de Wilde, Attorney at Axon Lawyers →
• Interaction between manufacturers and other economic operators: How to effectively implement PMS in the supply chain
• Marketing & Claims: How marketing, clinical evaluation and other MDR processes intertwine
Jacques Thielen, Consultant Medical Devices at QRS →
• Post-Market Surveillance and Vigilance, and the links to Clinical Evaluation and Risk Management
Emma Glass, University Partnerships Manager, Healthcare Technologies at BSI →
• Future-proof your device – How to manage changes in regulations and standards over the product life cycle
Erik Hansson, Senior Expert in Global Harmonisation of Medical Device Regulations →
• Global trends within medical device regulations
Cyrille Michaud
Managing partner at MD101 Consulting
Cyrille is a seasoned information technology engineer with experience in both software and Quality Affairs/Regulatory Affairs. Prior to his current position, he was Project Director from 2009 to 2011 at Olea Medical – a medical imaging start-up, where he headed the activities to achieve CE Mark and FDA clearances of Olea Medical products. From 2005 to 2009, Mr. Michaud was director of software projects at DCNS (military shipbuilder) managing several projects related to Data management and Graphical User Interface.
His key competencies are technical and regulatory issues, building business plans and developing design strategies for medical device software.
PRESENTATION:
Cybersecurity: How to deal with it throughout the Medical Device lifecycle?
Product managers, usability and UX engineers, software development teams, customer service, IT personnel, and end-users, discover how cybersecurity impacts all stakeholders in the medical device lifecycle.
Antti Virtanen
Solution Architect at Innokas Medical
Antti have long history, over 17 years, working with medical device development, design transfer and manufacturing at GE Healthcare and Innokas Medical in various positions in sales and R&D. Innokas provide medical device and IVD device development and manufacturing services, QA/RA consultancy and digital healthcare solution development. Antti’s current position is in the pre-sales to build the co-operation roadmaps with customer utilizing our expertise.
PRESENTATION:
Design transfer and contract manufacturing of medical devices – Practical tips and examples to mutually working relationship between customer and contract manufacturer
Innokas Medical has operated as a medical device contract manufacturer since 1994. Based on our experience we present some tips and examples learned over the years that are found to be challenges before or enablers of good relationship between customer and contract manufacturer. We are looking into topics such as selection of the right partner, the impact that decisions made in the development phase has on the manufacturing process, challenges related to the level of product maturity and completeness of the technical file, finding the right level of control over the partner and the importance of correct volume assumptions. Looking forward to seeing you in the audience!
Owner, Consultant, Entrepeneur at Diabetesia
Sofia is a chronic conditions patient entrepreneur, known as ‘Diabetesia’, living with type 1 diabetes and ulcerative colitis. With a passion for – and background in – marketing and communication, she has since 2015 made it her mission and heart matter to represent the affected people/patients/end users in various situations. Throughout the years that has included public speaking, blogging, arranging and attending events, social media presence, interviews and articles in national news, and consulting bigger companies (usually within the diabetes industry) with the important patient perspective.
PRESENTATION:
Medical Devices as Part of Your Daily Life – the User Perspective
Living with a chronic condition such as type 1 diabetes requires 24/7 self care with no breaks or “cheat days”. Access to today’s medtech allows me to shift focus to living rather than just surviving. During my session I will share my experiences of diabetes medtech in my everyday life and the opportunities and freedom my gadgets have provided me with throughout the years. I will also talk about the importance of involving the end user when developing new medtech.
Judith de Wilde
Axon Lawyers
Judith de Wilde is associate at Axon Laywers and combines her legal knowledge with her work experience in the medical technology industry.
During her study Judith researched the impact of Artificial Intelligence on the healthcare system. After graduating Judith worked as a legal counselor for an artificial intelligence-based start-up that operates in the e-health industry. At Axon Lawyers, she advices clients on legal and regulatory issues regarding medical devices and e-health.
PRESENTATIONS:
Interaction between manufacturers and other economic operators: How to effectively implement PMS in the supply chain
This session will focus on how manufacturers can ensure meeting their PMS obligations under the MDR by sourcing crucial PMS and PMCF data from the supply chain. Key items to address in a legal agreement with the distributors and other economic operators will be discussed, as well as some other tips and tricks.
Marketing & Claims: How marketing, clinical evaluation and other MDR processes intertwine
This session will dive into the interplay between concepts of marketing, clinical evaluation and other MDR processes and how to keep claims consistent between marketing statements and regulatory documentation. The relationship between marketing statements and controlled regulatory documentation in the QMS will be outlined, as well as the impact these concepts have on the dynamic processes of clinical evaluation and PMS/PMCF.
Åse Ek
Senior Consultant and Trainer at Key2Compliance
Åse has > 20 years experience within implementation of MDD/AIMD, MDR and ISO13485. Since 2017 I’ve been dedicated to deliver trainings in medical device Quality Management System, Risk Management and CAPA, as well as QMS aspects of the regulations. My mission is to support medical device manufacturers to efficiently implement regulatory requirements and find their key to compliance.
PRESENTATION:
Being the ‘Person Responsible for Regulatory Compliance’ –is this in fact a quality control, regulatory affairs, or both?
How can and should the requirements on the PRRC ‘Person Responsible for Regulatory Compliance’ be managed? The MDCG Guideline doesn’t provide much of an answer except that it is the responsibility of the manufacturer to ensure conformity of devices being released. We will take a deeper look into what it means, and methods that can be applied to demonstrate compliance, over time.
Josef Smeds
Managing Director, NordicInfu Care
With more than 20 years in the Medical Device industry, as Product Manager, Marketing Manager and Business Manager and more, Josef has acquired a deep understanding of the interaction between healthcare providers and the industry, at all levels, and learned how to device manufacturers can support and build relations with patients, physicians, and nurses as well as hospital directors
PRESENTATION:
How the industry work to meet both user needs, and expectations from the buyers
This presentation will focus on the interactions between medical device manufacturers and healthcare professionals and how device manufacturers can meet patient needs. This will sometimes involve work to build long term acceptance for innovative solutions not yet requested by their customers within healthcare organisations, but urgently wished for by the end users.
Christoffer Ekström
CEO at AI Medical Technology
Christoffer is the CEO at AI Medical Technology, a passionate Health Tech Entrepreneur and Computer Scientist with Master’s degree in immersive technologies (M.Sc.) at Stockholm University and is currently finalizing a bachelor’s degree in business administration (BBA) at Uppsala University. He is also an experienced climber and adventurer
PRESENTATION:
From user need to product specification – a real world example
Christoffer will share his story on how AI Medical Technology matched a critical user need with innovative technology and how AI powered diagnostic solutions will enable frontline healthcare practitioners to make faster and more reliable diagnoses for their patients. Dermalyse is currently undergoing clinical validation as a decision support tool for the diagnosis of all skin cancers.
Jocelyn Åkerberg
Stille AB
Jocelyn has a BSc in Medical Technology and worked in the Medical Device industry for over 10 years. In 2016 she started her career as an Auditor/Technical Specialist in Microbiology for the notified-body BSI in Germany, and from 2018 Jocelyn worked as a Product Specialist/Auditor at TÜV-SÜD in Germany. Jocelyn has been a member of the Technical Committee for Sterilisation at SIS and was nominated to represent Sweden as an expert, in the technical group committee for ISO 11135 – Ethylene Oxide Sterilization and EN 1422 – Ethylene Oxide Sterilizers.
PRESENTATION:
How Legal manufacturers shall control Contract manufacturers – the NB perspective
Under MDR it is presumed that legal manufacturers shall control outsourced production at the same level as their own (in-house) manufacturing while there is still no guidance provided on how that should be demonstrated. Jocelyn will share her view, based on her experience as NB auditor.
Jacques Thielen
Consultant Medical Devices at QRS
Jacques is an electronic engineer by education. He has extensive experience of the whole range of regulatory activities associated with medical devices, gained during his 25 years with Medtronic including Clinical submission, CE marking, Quality Systems requirements, Vigilance and Post Market Surveillance in EMEA, India and Latin America. He has been Vice Chairman of the MedTech Post Market Surveillance Working Group and as such participated to the European Vigilance Task Force.
Currently retired, Jacques continues to follow the MDR developments and provides consultancy in regulatory and quality matters.
PRESENTATION:
Post-Market Surveillance and Vigilance, and the links to Clinical Evaluation and Risk Management.
The presentation will cover all PMS aspects required by the MDR throughout the product lifecycle taking into account the associated processes Clinical Evaluation and Risk Management in order to optimize PMS activities. Focus will also be on Life-cycle management to ensure the medical device remains state of the art.
Emma Glass
University Partnerships Manager, Healthcare Technologies at BSI
Emma Glass is the University Partnerships Manager for Healthcare Technologies in the Knowledge Solutions division of the British Standards Institute (BSI). She is responsible for engaging with universities in healthcare technology research and innovation to promote participation and raise awareness of standards and standards development.
Recent work has included hosting an interactive workshop for MSc students on the value of standards in healthcare and collaborating with universities on innovative research projects in the sector. Prior to working at BSI, Emma launched new open-access science journals in digital health, nuclear medicine and radiology. She also authored CBP’s Big Data Focus Report in 2016 and 2017. Emma has a degree in English Literature from the University of Exeter.
PRESENTATION:
Future-proof your device – How to manage changes in regulations and standards over the product life cycle.
Medical device manufacturers often think about and plan for change only in the context of the device’s intended use or function, and have procedures and processes in place to identify and address the impact and risk of the change to the different phases of the device lifecycle. But in the current environment of innovation and rapidly changing technology and regulatory science, it is equally important to develop processes for monitoring, incorporating, and managing change to requirements in regulations and standards. This session will provide an overview of ‘state of the art’, requirements management, and how to incorporate change management into your quality system
Erik Hansson
Senior Expert in Global Harmonisation of Medical Device Regulations
In 2012 Erik joined the medical devices unit of the Commission to lead the implementation of the PIP Action plan, followed by the negotiations on the new medical devices (MDR) and in-vitro diagnostic medical devices (IVDR) regulations. Subsequently he lead the Commission’s operational team dealing with the implementation of the MDR and IVDR, was responsible for several EU working groups (such as MDCG), and headed the EU delegation to the multilateral regulatory cooperation in IMDRF and coordinated the cooperation with national Competent Authorities in the CAMD framework.
Erik retired from the European Commission in July 2021 but continues to head the EU delegation in the multilateral regulatory cooperation in IMDRF and is elected vice President of the Swedish section of the union of previous EU officials (AIACE). In 2022 Erik received the Founder’s Award from the US based Regulatory Affairs Professionals Society (RAPS) in recognition of a very significant contribution to the regulation of medical devices and leadership among international medical device regulators.
PRESENTATION:
Global trends within medical device regulations
While technological innovations are transforming the healthcare system, medical device regulations adapt more slowly. Can global harmonization reduce these hurdles? What’s on the agenda of medical device regulators, for example within IMRDF? What is the impact of MDSAP? ? Will the harmonization efforts cover also review of Technical Documentation, going forward? Erik Hansson shares his thoughts, based on his experiences of working within IMDRF and the EU Commission.”
Magnus Tägil
MD, PhD and Professor at the Orthopedic Clinic, at Skåne University Hospital, in Lund
Magnus is an entrepreneur with experience of start-up companies within orthopedic implants, e-health and pharmaceutics, and will share his experience of taking medical devices to the market and introduce new products and applications in healthcare organizations. With his long and broad clinical background he also has gained in-depth knowledge of the use of medical devices, and which aspects that are of critical importance to end users.
PRESENTATION:
How can device manufacturers meet user needs? Reflections from a healthcare perspective
