ISO 13485 and medical device quality systems - practical strategies for planning, implementation

July 13, 2011 - PRLog -- Why Should You Attend:

Whether you are experienced with your medical device quality system or are taking on the responsibility for the first time, it is a benefit to learn proven strategies from quality professionals with hands-on experience.
This session will discuss how to design and maintain your quality system to meet requirements to target the US, Canada and EU. We will also cover documentation and implementation planning, strategies for selection and interface with certification bodies and auditors, and getting value for your investment. You will learn practical tips to help with post registration maintenance, ongoing or expanded certification, and relationships with registrars and auditors.

Areas Covered in the Seminar:

- US, Canada and EU – know the requirements, build a single system.
- Planning your quality system – what you need now, what should happen later, who should help.
- Documentation – start from new, or build on what you have – make sure it works for your company.
- Implementation – how to's.
- Finding a registrar/Notified Body that will be a good fit for your company/scope/product(s)/budget – how to shop around and get the most from your investment; what to do if you aren't!
- Got your certificate - now what?

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Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates.