Name: Clinical Evaluation for Medical Devices
SKU: 967
Availability: InStock

Introduzione

The course is sold-out! We already reached the maximum number of attendees.
If you are interested in the next edition, please contact us ilaria.butta@lsacademy.site-dev.it

Significant regulatory changes are coming along with the EU Medical Devices Regulation 2017/745 (MDR), MEDDEV and MDCG (Medical Device Coordination Group) guidance evolutions affect the clinical evaluation of medical devices.

This online course gives participants an overview on the requirements for sufficient clinical data for medical devices and the impact of the MDR and guideline documents on clinical evaluation. The course further describes how to prepare 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 and MDCG Guidance on clinical evaluation for legacy devices, equivalence, and sufficient clinical data.

The training will allow participants to obtain a clear understanding of the regulatory requirements and will give hands-on insight on how to achieve compliance with respect to the changing environment and new documents to be created such as the summary of safety and clinical performance (SSCP) and periodic safety update reports (PSUR).

MODULE 1
Part 1: Overview on Medical Devices requirements

MDD vs MDR, what is new?
News on MEDDEVs, Standards, MDCG guidance
The ISO 14155:2019 revision
NB Guidelines on clinical evaluation
Impact on product claims and marketing

Part 2: The MDR requirements

MDR in a nutshell
Clinical evaluation and investigation
Equivalence approach

Part 3: Get ready to MDR from a clinical perspective

Gap analysis
Clinical strategy
Processes and strategy with NBs

MODULE 2
Part 4: MEDDEV 2.7/1 rev 4 and MDCG guidance on clinical evaluation

Overview and NB key points
Good practice for equivalence justification including MDCG 2020-5
Sufficient clinical evidence for legacy devices MDCG 2020-6
Risk assessment and clinical

Part 5: MEDDEV 2.12/2 rev 2 on post market clinical follow up studies (PMCF)

Overview on PMSP, PMSR, PSUR, CER, PMCF
When to conduct PMCF
PMCF plan and evaluation report templates MDCG 2020-8 and 7.
Role of the NB

Case studies / Q&A

CEO/CTO´s
Regulatory Affairs
Quality Assurance
Clinical Department
Marketing or Business Development responsible

Attendees’ experience
Knowledge of the medical device directive MDD 93/42 is an advantage. Newcomers are welcome.

Online training with case study discussion and Q&A sessions.

Docente/i

Info

Arkan Zwick

Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria

Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 15 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures in Vienna and speaks regularly at international conferences.

Durata e Informazioni utili
Quote Iscrizione

Online training – 2 modules

February 16th, 2021 9:30 am – 12:30 pm CET
February 18th, 2021 9:30 am – 12:30 pm CET

After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 720,00* (until 19 January 2021)

Ordinary: € 910,00*

Freelance – Academy – Public Administration**: € 430,00*

* for Italian companies: +22% VAT

**Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.