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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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Interesting Websites
10 Interesting Websites that have nothing to do with quality systems
Here they are, in no particular order:
- www.10best.com
By city, recommendations for hotels, restaurants, nightlife, etc. The anti-Frommers.
- www.uncommongoods.com
Look no further for that unique gift. The alternative to mall shopping.
- www.ranchostyle.com
Check out remodeled mid-century modern (1950s) homes in Long Beach, CA. One more thing to like about California!
- www.alexfritzglass.com
Alex is our neighbor, friend, and a talented glass blower. His wine glasses are gorgeous—check them out.
- www.seatguru.com
Don’t get caught in the airline seat that doesn’t recline. A website for airplane configurations by airline.
- www.quotationspage.com
You’ll never be at a loss for words again.
- www.npr.org/programs/specials/lists/sedaris
Readings from the hilarious, best-selling author David Sedaris on NPR. He is the funniest person on the planet.
- www.rangemart.com
Okay, maybe I’m biased. My husband owns Range Mart. You probably won’t have much use for his products unless you own a driving range, but you can order really durable mats for that person who’s crazy about golf.
- www.eyespyla.com
The 411 on things to do in Los Angeles.
- www.thesmokinggun.com
Large collection of public documents, celebrity mug shots, etc.
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