Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs 2019 is a webinar that covers topics such as:
- The purpose of the Medical Device Directives
- Regulatory status in relation to Medical Devices in the EU
- Directive Changes; Additional Requirements
- Meeting the New Requirements for Conformity Assessment by Product Type
- An overview of key areas of the Directive: Essential Requirements, Scope of application and definition, Medical Device Technical File, Medical Device Type & Process Path, Clinical Evaluations, Clinical Investigations and Notified Bodies
- The impact the Directive will have on marketing and developing new Medical Device products
- Guidance Documents available to assist in the implementation of these directives
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs 2019 intended for:
- Project Managers
- Clinical research and medical operations
- Manufacturing personnel
- Product Development personnel
- Quality Assurance such as GMP, GCP Auditors
- Researchers managing Medical Device R&D and Development
- Clinical trial supply personnel
- Regulatory affairs
- All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries)
- CRO personnel
