Live Online Training Course | Delivered In CET Time Zone
Medical Device School: Training Course
Gain A Comprehensive Understanding Of The Medical Device Regulatory Landscape To Accelerate The Path To Compliance
Develop The Knowledge Base Necessary To Ensure Global Submission Best Practice And Streamline Market Access
The Expert Led Training Course For Medical Device Professionals New To The Regulatory Field Or Seeking A Refresher
Course Overview
Course Trainers:
European Commission, DEKRA, TEAM-PRRC, Philips Healthcare, Novocure, Geistlich Pharma AG, Covington & Burling LLP, Qserve Group, Czech Metrology Institute, Smith & Nephew, Intrinsic Medical Group LLC, Human Care HC AB, Steris
Agenda overview:
Medical Device School is an engaging and interactive live online training course, designed to give you a solid understanding of the very fundamentals of the medical device industry and your role within it. Navigate through the entire medical device lifecycle in this 3 day course, from introductions to all stakeholders in the medical device ecosystem to regulatory pathways for device approval and post-market considerations. Benefit from engaging with fifteen specialised trainers, all of whom have extensive first-hand experience with bringing medical devices to market and adhering to the complex global regulatory landscape.
What will you learn?
Navigate the Current Medical Device Regulation (MDR)
Understand the key requirements of the EU MDR
Explore the full medical device ecosystem
Understand the roles of different stakeholders and how they interact to bring devices to market
Device regulation essentials
Get to grips with the fundamentals of device regulations including classification and conformity assessment
Biocompatibility
Discover the importance of biocompatibility and how to conduct biological evaluations in line with ISO 10993 standards
Risk Management
Risk management - Examine the importance of having a robust risk management plan
Clinical Investigations And Evidence For Devices
Understand clinical evaluation, investigation and evidence requirements under the EU MDR. And explore the links to risk management, biocompatibility and PMS.
Implementing A Quality Management System
Understand the need of having a quality management system (QMS) in place, the latest ISO 13485 guidance and MDSAP considerations.
Post Market Surveillance and Vigilance
Understand the importance of post market surveillance (PMS) and vigilance to ensure your devices continue to be safe on the market. Explore the impact of the EU MDR / IVDR on PMS requirements, risk management, processes for complaints, adverse events and corrective action.
UKCA: UK Market Access
Examine the status, challenges and evolving requirements of the UKCA mark and how to launch medical device products on the UK market.
Drug Device Combination And Borderline Products
Learn how Drug Device Combination Products and Borderline Products are defined and how they differ. Get to grip with Article 117 (MDR), the structure of MDCG 2022-5 and specific requirements.
Labelling Requirements
Uncover the current label content requirements for EU and UK markets, labelling strategies and electronic labelling.
Who is this course for?
The school is designed for all those who want to improve and broaden their knowledge of the medical devices industry, whether you are an existing employee, graduate, new to an area/department or somebody who would benefit for future career development.