Understanding and Implementing the Medical Device Directive - Seminar By ComplianceOnline

Course Description :-

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.

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

Instructor :-

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.