Medical Devices: EU Directives, Guidance Documents, CE Marking Process, ISO Certification ……and the NEW Impending EU Regulations

Website https://www.demystifiedsolutions.com/trainingDetails/Medical-Devices-EU-Directives-Guidance-Document | Edit Freely

Category

Deadline: May 23, 2017 | Date: May 23, 2017

Venue/Country: Online

Updated: 2017-03-10 15:30:15 (GMT+9)

Call For Papers - CFP

Why Should You Attend

This course is focused on understanding the requirements of the Medical Device Directives / Regulations, their linkage to the EU Clinical Trial Regulation and the requirements of CE Marking and ISO Certification on commercializing products. The course covers all relevant topics in brief associated with the Directives and Guidance Documents, the reasons behind their introduction and a review of methods for effective implementation.

Areas Covered in this Webinar

Definition: Medical Device or Personal Protective Equipment.

Overview of the Global Medical Device Industry

Standard

Active Implanted

In Vitro Diagnostic

Combination Products; Drug or Biologic + Device- Interface with Other Directives and How It’s Treated from a Regulatory Perspective

An Overview of the Medical Device Directives.

Development, aims, implementation and update of the Medical Device Directives

Implication of an EU Directive vs. Regulation

Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combination Products

Update on the additional guidance documents relating to the directives

Essential Requirements

Classification of MD's and Process Implications

Conformity Assessment

Technical File

Relationship to EU Clinical Trial Directive

Guidance Documents.

Medical Device Directive Annexes.

Compliance Requirements by Type

Full Quality Assurance System

Declaration of Conformity

Safety.

Medical Device Vigilance System

Manufacturer's Requirements

GMP

GCP

CE Marking

ISO Certification

Clinical Trials

Labeling

ISO Standard Certification.

Overall process; Management Commitment & Involvement

Role of Notified Bodies

Relationship to CE Marking

ISO-13485 (Manufacturing) & ISO-14155 (Clinical Investigation & Evaluation) Overview, Conformity, Auditing and Harmonization to International Standards

Compare & Contrast EU & FDA Procedures and Requirements.

Process Similarities & Differences

Implications for Industry

Company Management

Process Changes

Management Team Effectiveness

Regulatory Approval and Liaison with Regulators

When and How to Influence Regulators

Do's and Don'ts of Regulatory Involvement

Learning Objectives

Upon completion of this course attendees will have a thorough knowledge of the requirements for developing and marketing Medical Devices across the European Union. The Directives are complex and the requirements differ somewhat by Member State. The content of this course is designed to simplify the understanding of all requirements and to provide attendees with the latest information regarding interpretation and enforcement of these regulations.

Who Will Benefit :

This workshop will be of great value to Medical Device professionals and those involved in the registration of Medical Devices across the EU. It is primarily designed to benefit the following disciplines:

- Clinical research and medical operations

- Project Managers

- Product Development personnel

- Manufacturing personnel

- Researchers managing Medical Device R&D and Development

- Quality Assurance such as GMP, GCP Auditors

- Regulatory affairs

- Clinical trial supply personnel

- CRO personnel

- All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (30 expanded EEA countries)

For More Info, Please Click below URL:

https://www.demystifiedsolutions.com/trainingDetails/Medical-Devices-EU-Directives-Guidance-Documents-CE-Marking-Process-ISO-Certification-……and-the-NEW-Impending-EU-Regulations-DEMY051453