CfPIE - The Center for Professional Innovation & Education, Malvern, PA USA
June 27 & 28, 2018
Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
Things are changing for Medical Devices and IVDs in the European Union (EU): new fundamental standards, new EU device regulations and BREXIT. What is now needed to enter or, more importantly, to maintain presence in this attractive marketplace for medical devices? Satisfying requirements harmonized across the 28 member states should be a straightforward process to get products approved for distribution in each country - but is it?
This course identifies and explains the requirements – old and new – for medical devices, the steps to obtain entry into the marketplace (including setting up on-going procedures and relationships), the increasing importance of Clinical Evaluation and Post Market surveillance, Notified Bodies and Competent Authorities. The course also shares some lessons learned from the Course Director, who has over 25 years of experience with CE marking medical devices for distribution in the EU.
The course will describe the Medical Device Directives (AIMD, MDD & IVDMDD), and introduce the new Medical Device & In Vitro Device Regulations (MDR, IVDR) identifying the impact of these changes. Also covered is the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the roles of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, the updated ISO 13485 and ISO 14971 standards, and reference to ISO 14000. The importance of these standards as necessary elements in addressing the Essential Requirements (and the General Safety & Performance Requirements), technical files, declarations of conformity and the six steps required for manufacturers to market Medical Devices in the European market.
Throughout the course, examples and case studies will help participants apply the concepts being covered and with the extensive resource material provided, prepare attendees for the three-year transition period to the new standards and the new EU Regulations.
With the three-year transition clock running, Regulatory and Compliance professionals are strongly encouraged to attend.
Who Should Attend
This course will be of great value to medical device professionals involved in marketing and supporting medical devices in the European Community. It is primarily designed to benefit the following disciplines and personnel:
- Regulatory Affairs
- QMS & Compliance Management
- Product Managers
- Sales & Marketing
- Product Development
- Quality Assurance
- Research and Development
- Risk Management
- Clinical Affairs
Jonathan Lee has more than 25 years of broad-based medical device experience with extensive Quality System experience encompassing ISO, MDD & GMP standards and regulations, through consulting and senior management positions in QA/RA, R&D, Project Management, Product Management, and Product Introduction disciplines, in both the United States and Australia.
A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic. In addition, his consulting roles supporting implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation system, surgical tool, vertebral stiffness measuring system, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, and product approvals, have provided for an extensive accumulated experience.
Today, as Principal Consultant and Managing Member of “MedDev Consulting Solutions International” he provides strategic direction and tactical solutions for unique medical device challenges. Including areas such as integration of quality systems with compliance, product performance and elevated stakeholder expectations.
Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University. He has participated in compliance symposia at Harvard University and served as an instructor on quality systems at University of Southern California School of Pharmacy Master’s Degree Program.