סמינר איכות בפיתוח מיכשור רפואי והרגולציה האירופאית

Design controls and their implementation according to ISO-13485 and the new regulation in Europe for medical devices (EU MDR) are critical for the compliance of the technical documentation and obtaining the CE mark for sale in Europe. What are the design controls and how are they reflected in the European regulation? Experts in the field will discuss this in a half-a-day seminar.

Agenda:

09:30-10:00  Gathering and light refreshments

10:00-11:15   Design Controls requirements in medical device development according to ISO-13485: 

                      Content of the Design History File (DHF), including all elements required by standard.

11:15-11:30    Break

11:30-12:45   Implementation of Design Controls requirements according to EU MDR:

                      EU MDR Overview, Significant changes, Clinical evaluation, Post-Market Surveillance (PMS), and more. 

12:45-13:00  Summary and Q&A session

Intended for: Employees and managers of medical device companies: CEOs, quality and regulatory managers, design and product managers, engineers.

About the speakers:

Helit Dovrin - Executive Consultant, Auditor, Lecturer and Coacher worked for more than 25 years as Quality and Regulatory Senior Leader at the world leading medical device companies such as: Philips Healthcare, GE Healthcare, Align Technology and Biosense Webster part of Johnson & Johnson. 

Helit gained experience & expertise in all areas of the Quality Management System and Regulatory Affairs including FDA & Notified Body Inspection Management, ISO-13485, EUMDR & MDSAP Compliance Audits, and Quality & Safety escalations.

Daniel Albahari - Principal Consultant and Founder of BioReg Services, a boutique consultancy based in Jerusalem (www.bioregservices.com). Daniel has more than 17 years of experience in medical device industry, consulting for international and local companies focused on regulatory and quality issues in Europe, US, and Israel. Daniel’s specialties include regulatory strategy, EU-MDR, Clinical Evaluation, Post-marketing strategy, 510K submissions and ISO 13485 Quality Systems. He holds a M.Sc. in Biochemistry from the Hebrew University of Jerusalem, and a RAC certification.