Discover the course
The Medical Device Clinical Evaluation
Understanding the clinical evaluation requirements for the MedTech industry
Latest news from MDR 2017/745 and ISO 14155!
Significant regulatory changes have come along with the EU Medical Devices Regulation 2017/745 (MDR) and MEDDEV evolutions affecting the medical device clinical evaluation. This course gives participants an overview on the requirements for the clinical evaluation of medical devices and the impact of the MDR and guideline documents on clinical activities. Get prepared for the new requirements from a clinical perspective including the MEDDEV 2.7.4/1 on clinical evaluation and the MEDDEV 2.12/2 on post-market clinic follow up!
A clear understanding of the regulatory requirements will give you an important tool to be fully compliant.
Module 1: Overview on Medical Devices requirements
- MDD vs MDR, what is new?
- Clinical MEDDEVs and Standards
- The reviewed ISO 14155:2019
- NB Guidelines
- Impact on product claims and marketing
Module 2: The MDR requirements
- MDR in a nutshell
- Clinical evaluation and investigation
- Equivalence approach
Module 3: Get ready to MDR from a clinical perspective
- Gap analysis
- Clinical strategy
- Processes and strategy with NBs
Module 4: MEDDEV 2.7/1 rev 4 on clinical evaluation
- Overview and NB key points
- Good practice for equivalence justification
- Risk and clinical assessment
Module 5: MEDDEV 2.12/2 rev 2 on PMS
- PMSP, PMSR, PSUR, CER, PMCF
- When to conduct PMCF
- Role of the NB
Case studies / Q&A
Mr. Arkan Zwick is the Corporate Regulatory Affairs Director of CROMA Pharmaceutical, Austria. CROMA is a private global pharmaceutical and surgical company with products in ophthalmology, orthopedic and aesthetic dermatology. With more than eleven years of regulatory professional experience Arkan´s role includes regulatory advocacy for drug, medical device, combi products and cosmetic compliance projects as well as in house legal advice for contract management, merger and acquisition, and intellectual property projects. He is responsible for the company’s regulatory compliance in the EU working with several notified bodies and for global market authorizations in the Americas and Asia-Pacific.
Arkan has a master’s degree in Law from the University of Vienna and a PhD in European Law. His expertise includes in house legal and regulatory consulting as well as lecturing at the University of Applied Sciences in Vienna and scientific board member and speaker on life cycle conferences and trainings. He is fluent in English, German and French.
Quality Assurance, Regulatory Affairs, Clinical Operations, Medical Writing, Research & Development, CEO / CTO´s working for medical device manufacturers, pharma and biotech companies, CROs, Research Centres and Universities applied sciences and biotechnology faculties.
Knowledge of the Medical Device Directive (MDD) 93/42 is an advantage. Newcomers are welcome.
5 training Modules
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 880,00*
Ordinary: € 990,00*
Freelance - Academy - Public Administration**: € 490,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Wednesday, December 30, 2020
At the end of the training, you will be able to
Understand the content of the MDR and its impact on the medical device clinical evaluation
Understand new elements in ISO 14155
Understand how to achieve compliance during the transition period
Take advantage of the practical experience from industry expert