Audio conference highlights
The Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) have been significantly changed by the European Amended Device Directive (2007/47/EC), and many of these changes are expected to become active in March 2010. Clinical evaluations must follow a well-defined and methodologically sound procedure. In this audio conference, the speaker describes these expectations for clinical evaluations and provides suggested templates for clinical evaluation reports (literature reviews and clinical studies).
This session provides valuable information to Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. It also provides important insights for regulatory, clinical and quality departments within device manufacturing companies, as well as to CROs and consultants who are assisting these companies with their 2010 compliance preparations.
This audio conference covers:
- Description of changes to the MDD and AIMDD
- Understanding the need for clinical data
- The use of templates for clinical evaluations
- How to identify required elements of a clinical study evaluation
- An appreciation of basic literature review standards
About the speaker:
Joy Frestedt, PhD, is the President/CEO for Frestedt Incorporated (
www.frestedt.com), a consulting group of over 50 experts providing services in the broad areas of clinical trial development and execution, as well as US and international regulatory compliance, medical writing and management of corporate quality systems. Frestedt Incorporated is a novel virtual network of highly skilled staff meeting specific needs for large and small projects.
Dr. Frestedt has over 25 years of experience running clinical trials, submitting regulatory documents, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally.
Who should attend?
- Clinical Research Managers
- Quality Affairs Directors/Managers
- Regulatory Affairs Directors/Managers
- CRO Specialists & Consultants
- Quality Auditors & Inspectors
*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.