Understanding and Implementing the Medical Device Directive

(www.complianceonline.com)

Course Description

"Understanding and Implementing the Medical Device Directive" - This course is certified by RAPS. Attendees are eligible for 12 RAC points on completion of the Seminar.


Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different than the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency.

This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it. During the course, participants will have exercises that apply the principles and help solidify learning.

The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.

Course Objectives:

Understand the role of product directives in the EU
Learn the medical device classification system and how to apply it
Comprehend the conformity assessment paths and how they apply to particular devices
Understand the Essential Requirements and how to document compliance
Learn the role of ISO 13485 as the fundamental Quality Management System
Understand the requirements for Risk Management and the use of ISO 14971
Integrate the Clinical Requirements in the MDD into the essential requirements and risk management processes

Who will benefit

This course benefits anyone involved in quality or regulatory compliance for medical devices marketed in the European Union and is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

Regulatory Managers
Quality Managers and Directors
Marketing Managers
Clinical Managers
Export Compliance Managers

Meet Your Instructors

Dan O’Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.