European Union Medical Device Regulatory Update
Schedule:
- 21 October 2008, 1:00 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: The key EU regulatory/quality processes, the Medical Device Directive, EN/IEC 60601 and EN/ISO 14971 have all recently been updated. Don’t go into your next surveillance assessment without accommodating these new and updated requirements. This webinar outlines these changes and discusses the potential impact they will have on your regulatory and quality processes, the status of your regulatory approvals and your current R&D activities and will include insight you can use on:
- Risk classification
- Technical Files and Design Dossiers
- Risk management assessments
- Product testing (particularly electrical safety testing)
- Labels, instructions for use and technical documentation, and
- Transition dates
Description: Obtaining a CE Mark is an extremely important regulatory achievement. Europe represents an increasing lucrative market; obtaining and maintaining access to that marketplace should be a high priority for your company. European regulatory processes are in a virtually constant state of change – new requirements, new Harmonized Standards, Environmental Programs and even new countries joining the Union. Staying current is a full time job, gaining access to the EU and other jurisdictions where the CE Mark is accepted, makes the effort more than worthwhile. Don’t suffer the embarrassment of having your product seized at the border or even removed from a hospital’s or the distributor’s shelves. This webinar delves into the changes themselves. This is not an introduction to CE Marking.
Who should attend: This webinar is ideal for regulatory compliance, quality management staff and those individuals who have to manage processes, conduct research and development, organize product testing or prepare regulatory applications and includes those who must interact with auditors and inspectors.
Presenter: Tim Duggins, Horizon Phoenix’s Senior Partner has more than 25 years experience in medical device quality systems and product testing. Tim is a skilled and fully accredited consultant and auditor with extensive experience implementing fully compliant regulatory and quality systems using EN/ISO 13485, USFDA QSR, Health Canada CMDR and/or all medical European Directives for more than 100 clients. An avidly sought after expert, he served as a consultant to such diverse organizations as federal governments, international non-governmental organizations, and industry from multi-national manufacturers to a three-person niche-market company. Tim has participated on numerous national and international committees writing product testing standards and helping create government regulatory processes; his product experience spans the entire medical device spectrum from high volume injection molded disposable products, digital radiography systems, in vitro diagnostic test kits to implantable cardiovascular devices.
Expert contributor: TBA
Expert contributor: TBA 18 Mar 2008
Registration:
$295
Registration for Oct 21st will
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