Bringing a medical device to the marketplace is a complex and lengthy procedure which requires experience, knowledge and specialist skills. The contribution to successful market placement comes from many different skilled individuals and organisations who should be aware of all the stages involved and be able to relate their responsibilities to the needs of other professionals, scientists, clinicians and regulatory and quality experts.
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process. The programme will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, practical workshops and case studies covering each process applicable to device development, marketing and, eventually, postmarket procedures. There will be ample time throughout the five days for informal discussions
with our expert faculty and fellow professionals.
Benefits of attending:
Understand the procedures for taking a medical device to the marketplace
- Learn what regulations control the manufacture and marketing of devices in the EU
- Ensure compliance with the MDR
- Gain an insight into different aspects of the process for obtaining the CE mark for a device
- Discover a holistic approach to device development and marketing
- Participate in workshops and learn from other people’s experiences
- Understand how other professionals affect the process for bringing a device to market
- Network with participants from organisations similar to your own
Certification:
- CPD: 30 hours for your records
- Certificate of completion
Agenda
Day One
What is a Medical Device?
- Definitions and examples
Device Design and Development
- Overview
- Device innovation
- How is a device developed from concept?
- From idea to market, the overall steps
What Regulations Control the Manufacture and Marketing of Devices in the EU?
- A brief history of the Medical Device Directives explained (AIMDD, MDD and IVDD)
- An overview of the Medical Device Regulations 2017/745
How Does a Device obtain a CE Mark?
- What does the CE Mark mean?
- Overview of the CE Mark process for a device
- Device classification
UKCA
Economic Operators, Competent Authorities and Notified Bodies
- Who are economic operators and what are their responsibilities?
- What is a competent authority?
- The role and responsibility of a competent authority
- What is a Notified Body?
- The role and responsibility of a Notified Body
- Relationships with manufacturers
Classification of Medical Devices
- How do you classify a medical device?
Classification workshop with case studies
Day Two
Risk Analysis and Risk Management
- Review of ISO EN 14971:2007, ‘Medical Devices Application of Risk Management to Medical Devices’
- What procedures must a manufacturer follow?
How Should a Risk Analysis be Conducted? - Risk Analysis Workshop
Biological Evaluation of Medical Devices
- ISO 10993 and the biological safety assessment process
- Where product safety assessment fits in New Product Development
Technical Files and Design Dossiers
- What are these documents?
- What should they contain and how should they be presented?
Quality Systems for Medical Devices
- What is a Quality System?
- What do manufacturers need to do to implement a Quality System?
- What are the regulations and guidelines for Quality Systems?
Labelling and Packaging of Devices
- What information needs to be provided and how should it be set out?
- What regulations and guidelines should be followed?
Day Three
Regulations and Guidelines Applicable to Medical Device Studies
- Review of ISO 14155 and other available guidelines
Clinical Evaluations
- How to conduct clinical evaluations
- Controls of the clinical evaluation plan and clinical evaluation report
- Literature search
Conducting Medical Device Clinical Investigations
- How to conduct medical device clinical investigations
- Study design
- Study content
Documents Necessary for Medical Device Clinical Investigations
- Clinical investigation plan
- Clinical investigation report
Clinical Investigation/Evaluation Workshop
Approvals for Conducting Clinical Studies
- Documents required
- Ethics committees
- Competent authorities
Day Four
In-Vitro Diagnostic Products
- The IVD Directive
- New IVD Regulation (2017/746)
- Transition period preparation
- Impact on compliance and risk analysis
Software and Medical Devices
- Understanding the requirements for medical device software
- Software qualification and classification
- Clinical evidence for medical device software
- Additional considerations for Artificial Intelligence
Making Sense of the European Reimbursement Environment
- Making sense of reimbursement, regulation and market access
- Understanding different approaches adopted to the reimbursement of medical devices
- Implications for manufacturers of medical devices
Drug/Device Products
- Regulations for demarcation of medicinal products and devices
- Exploration of borderline issues
- Quality considerations
Devices Incorporating Materials of Animal Origin
- What’s the risk?
- Specific standards on animal materials
- Conformity assessment for devices containing animal-derived materials
Day Five
Post-market surveillance (PMS)
- What constitutes PMS? The basic principles
- The regulatory requirements for PMS
- The increasing importance of PMS
- A review of available guidelines for PMS
EC Medical Device Vigilance
- Basic principles
- Reporting arrangements
- Role of manufacturer, competent authority and Notified Body
- Review of the available guidelines for device vigilance
Workshop with case studies
Speakers
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
NAMSAJanette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.
Zuzanna Kwade,
Agfa HealthcareZuzanna Kwade is Medical Affairs Manager, Agfa Healthcare. Zusanna holds a PhD in Biochemistry and has more than ten years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research.
Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represents COCIR in the European Union Task Force on clinical evaluation of software.
Mr David Howlett,
Director ,
PharmaDelivery Solutions LtdDavid Howlett is the Director of PharmaDelivery Solutions Ltd. In 2003 he established the company as a highly specialised consultancy service in the field of drug delivery device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis, establishing design control systems and design verification, planning and execution, materials strategies and type III device Drug Master Files (DMFs).
PharmaDelivery Solutions Ltd has provided key programme inputs in various forms including due diligence, regulatory GAP Analysis, strategic and detailed planning, implementation, mentoring and training.
In addition to activities supporting commercial organizations, has been involved in the following roles;
Honorary Teaching Fellow in the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester and is author/ tutor for the Pharmaceutical Industry Advanced Training (PIAT) MSc module on Inhalation dosage forms
A UK national expert representing the British Standards Institute developing international standard ISO 20072:2009 for pulmonary and nasal delivery, and a committee member on other standards committees
Worked with the United Nations and various national governments to develop and establish transition strategies from the use of CFC in Metered Dose Inhalers and to secure appropriate budgets from the Multi-lateral fun for the implementation of the Montreal Protocol
An invited speaker at a number of international meetings and symposia on device development related subjects, including regulatory expectation, DPI development, extractables and leachables control and emerging markets
Mr Will Burton,
Director ,
Russell Square Quality Representatives (RSQR) LtdWill Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.
Paula Wittels,
Translucency LtdKey positions held in career
Programme Director Translucency Ltd
Director of Operations Quintiles Consulting, specialising in medical device reimbursement
Marketing Director Howmedica International (at the time a Pfizer company) manufacturing orthopaedic implants
Group Product Manager Amersham International (now part of GE healthcare). Launch of novel IVD platform
Major areas of expertise
Experience across a wide range of medical technologies
Business planning
Market assessment
Product management
Services offered through Translucency
Early commercialisation
Market access
Product reimbursement
Management of multi-country projectsEducational and professional achievements
PhD in Public Health
MA in Natural Sciences (specialist subject biochemistry)
MSc in Information Science
Member of the Chartered Institute of Marketing
Speaker on medical device reimbursement at conferences
Stuart Angell,
Director ,
IVDeology LtdStuart Angell, This MDTI expert is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
Adrian Keene,
NAMSAAdrian Keene is Director, Product Development Strategy at NAMSA, where he utilises his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He was previously Head of Notified Body for the UK Notified Body SGS. Prior to that he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Devices Directive.
In this role he combines his experience from new product development with EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products.
Adrian has 25 years experience in the medical device industry, and previously held the role of Technical Manager – Medical Devices at the Notified Body LRQA. Prior to that he worked in the medical device industry, latterly as Global Product Safety Manager at Smith and Nephew. Here he created a highly effective team delivering product safety and risk management to Smith and Nephew’s global wound management portfolio. His team was responsible for providing toxicological and risk management strategies to expedite product launches, commercialisation, and post market activities, including Far Eastern markets (Japan and Korea).
He joined Smith & Nephew directly from The School of Pharmacy (University of London) following postgraduate research in retinoid-induced skeletal toxicity and an honours degree in Toxicology and Pharmacology. He also holds a Diploma in Managing Medical Product Innovation from the Scandinavian International Management Institute.
Adrian is a UK expert for ISO/TC 194 (Biological Evaluation of Medical Devices), and has been an active participant in NB-MED and NBRG
Ms Theresa Jeary,
Technical Manager for Medical Devices ,
Lloyds Register Quality Assurance (LRQA)Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.
Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
Who Should Attend
This event has been designed primarily for those who wish to understand the processes involved in bringing a medical device to market. General medical devices as well as active implantable, in-vitro diagnostic and drug device products will be covered in the programme.
The course will be of particular interest to those seeking to introduce new medical devices to the market. Previous delegates who have benefited include regulatory, quality, clinical and marketing managers.
