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The Medical Device Directive 93/42 EEC as Amended by 2007/47 EC—Are you Ready?
Manufacturers must be in full compliance with the changes that apply to them by March 21, 2010.
Changes to the Directive include, but are not limited to:
- Re-Classification of some devices that impact the central circulatory system
- Record retention
- Increased emphasis on clinical data (required for all devices, regardless of EU classification)
- Software classification
- Conformity assessment options-class I manufacturers may choose Annex II
- More in depth review of technical documentation by Notified Bodies
- Usability/ergonomics per EN 62366
- Overlap with Machinery Directive 2006/42 EC
It is critical that each manufacturer review 2007/47 as well as related guidance documents to determine what changes are applicable and the impact of the changes. Reviews should be documented and with justification for those requirements deemed not applicable.
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Welcome to ADVQSS
Welcome to ADVQSS website. ADVQSS is a full service consulting company specializing in the medical device industry. Its’ goal is to offer clients timely, cost-effective solutions to quality system compliance issues.
Many times, an organization’s automatic response to compliance deficiencies is to generate another piece of paper—SOP, work instruction, or form. The cumulative effect is a quality system driven by paper (or electronic documents) and an organization swimming in documents—many of which employees aren’t even aware exist.
Unlike many consultants, I do not subscribe to the “more is better” theory. I’ve seen 70 page Quality Manuals that are so generic that they do not even state the quality system scope. ADVQSS provides clients with a Quality Manual typically 8-10 pages. Other quality system documents are written in a similar fashion—succinct and appropriate for the intended audience.
ADVQSS is here to help, whatever your quality system compliance needs are.
View my PowerPoint presentation:
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