ISO 13485: Can it be applied to Clinical Trials?

Is Quality King?
In the medical device manufacturing business we never stop hearing about quality; from the time the product is a twinkle in someone's eye until it finds it's way to the landfill, quality management is a preeminent concern. Quality is regulated through 21 CFR Part 820 in the States, and through the three medical device directives in Europe; but actual implementation is a horse of a different color. This is where ISO 13485 is useful--it gives you a framework for getting your quality management system in shape and under control.

A Conceptual Overview...
The hardest part is getting employee buy-in: until they know what quality means, agree that it is important, and believe that management agrees it is important, your quality system dreams will remain in the clouds.

That said, the first step it to document what you've got. Second step is to understand what you need. Third step is to use the tools of ISO 13485 to move from step one to step two. ISO 13485 is a toolbox for building a country-compliant quality system.

A Factual Overview...
ISO 13485 approaches quality by aiming straight at management. Through a documented and version-controlled Quality System Manual, management defines quality within the context of the devices the company manufacturers, and then adds the remaining tiers of a quality system: an operations manual, operating procedures, and record-keeping systems. The result is (hopefully) the understanding and control over cradle-to-grave quality that every company needs.

Finally, if you want a certified quality system, you'll choose a registrar with credibility in your countries of business, submit to inspections, and issue a shiny press release when you succeed.

You will receive:
1. A speaker with experience.
2. Clarity about your options.
3. Advice on choosing a registrar.
4. PowerPoint slides

The presenter:
Rod Ruston, Owner of Priory Analysts, has work with ISO 2001 (parent to ISO 13485) since before the first version in 1987, and on quality system for more than twenty years. He will be happy to assist you in achieving ISO 13485 certification.

He served on several of the European Commission Committees charged with implementation of the European Directives on medical devices. He was instrumental in creating the RAPS Certification in European Regulatory Affairs, and was winner of the Leonard Stauffer Award in 2006 recognizing exceptional contributions to furthering regulatory affairs professional development.

Based in Milton Keyes, UK, Rod brings an across-the-pond humor to business solutions in regulatory affairs and quality assurance.

Audience suitability:
[x] Regulatory professionals.
[x] Quality systems professionals.
[x] Engineers who design or develop medical devices.
[x] Production managers who are concerned about quality.
[x] Executives who are planning their company's futures.

The purchase is $425 for OnDemand access and $445 for the CD. Event materials are available by download for OnDemand or are on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.