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

Instructors: Cathie Rutt , Nancy Ruth 
Product ID: 702036
  • Duration: 70 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This medical device quality systems training will show how you can design and maintain your quality system to meet requirements to target the US, Canada and EU.

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?

Who Will Benefit:

  • Medical Device companies or companies with mixed product lines that include devices
  • Quality Manager
  • Quality Specialist
  • Quality Representative
  • Regulatory Affairs Professionals
  • Management responsible for quality system project
  • Consultants
  • Others tasked with quality project leadership responsibilities

Instructor Profile:

Nancy Ruth, has had a career spanning more than 30 years in health care, quality systems and regulatory affairs, in clinical laboratories, blood services and consulting.  Her hands-on quality system experience includes Good Manufacturing Practices (GMP), ISO 13485 and  ISO 9001.  She is a Certified Quality Auditor (ASQ), RABQSA Provisional Quality Management Systems Auditor and is certified (RAC) by the Regulatory Affairs Professionals Society. She currently manages the medical device consulting group at CanReg Inc, providing medical device regulatory and quality systems services for Canada, US and EU to a wide range of clients.

Cathie Rutt, has over 20 years experience in the pharmaceutical industry, including positions in sterile injectables, hard tissue replacement, active pharmaceutical ingredient manufacturing, and medical devices governed by GMP (Canada and US), GCP, ISO 9001:2008, ISO 13485:2003, and CFR 21 Part 820. Cathie is currently the Associate Director, Medical Device Quality , consulting with  clients to create and maintain quality systems.

Nancy  and Cathie have worked collaboratively with many clients, from small start ups to large companies, developing, implementing and maintaining  successful quality systems for regulatory compliance.

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