ISO 9001:2008 is no more just QMS, it is now a Business Management System that requires you to do RISK Management when designing the QMS. You have to understand the Risks to the business, and determine the Processes to be develoed. This may require you to do HACCP studies, if you are a food processor, and understand Product liability and the implications of Product Recall as in ISO/PC 240. For guidance in designing your QMS, you must refer to ISO 9004:2009.
CE Marking, EU Directives, and Guidance Documents
DescriptionImprove your sales and increase customer satisfaction with medical devices that bear the CE Mark, allowing them to be legally sold within the European Union (EU) and the European Free Trade Area (EFTA). Get a clear understanding of the European directives to ensure that your products meet designated minimum safety standards and quality levels, while minimizing liability risks associated with noncompliance. Ensure your product can move freely throughout the European Single Market.
Intended for medical device manufacturers who want to export to Europe, this two-day course provides an overview of the following EU directives: Active Implantable Medical Device Directive (AIMDD), Medical Device Directive (MDD), and the In Vitro Diagnostic Device Directive (IVDD). Also covered are the requirements for safety, health, environment, and consumer protection set forth by the European medical device directives.
CE Marking, EU Directives, and Guidance Documents Topics:
Designed for professionals in quality and regulatory affairs who are responsible for preparing or hosting CE Marking audits; U.S. and Canadian organizations new to the EU market; personnel performing design and risk analysis for medical devices under development; and companies preparing their own private labeling for medical devices marketed in Europe.
|UL University's workshops are designed for and intended to serve individuals using and relying upon UL services. UL University reserves the right to limit workshop attendance strictly to the foregoing. In addition, UL University reserves the right to change, reschedule or cancel any workshop at any time. UL shall not be responsible for any consequential or other losses resulting from the cancellation or postponement of this workshop such as airline and other travel/personal expenses.|
if NO RELIGION
no HOLY WAR
IMAGINE if no COUNTRY
nothing to kill or die for
IMAGINE all the ppl living in PEACE and Harmony
Yes I m a DREAMER
my buddy Jesus too
John Lennon too
MK Gandhi too
Dr Rev Martin Luther King Jr too
|“There is only one boss. The customer. And he can fire everybody in the company from the chairman on down, simply by spending his money somewhere else.”|
Responsibility of manufacturers
The CE marking must be affixed by the manufacturer or his agent established within the Community. The manufacturer bears ultimate responsibility for the conformity of the product.
Conformity assessment relates to the design and production phases of the product. Depending on the conformity assessment procedures applied, a notified body may be involved in these two phases. If the notified body is involved in the production control phase, its identification number will follow the CE marking.
If a product falls within the scope of a directive that provides for the CE marking, this should be affixed: