Understanding ISO 13485: 2015 Requirements for Medical Devices

Duration: 75 Minutes
The speaker will provide the background behind ISO 13485: 2015 and identify all areas that are being changed from the current ISO 13485: 2003 requirements for medical devices manufacturers. Steps involved in updating your current quality system to fulfill the updated quality requirements will be discussed. Timelines for compliance to the new standard and recommended steps will be clearly identified for the audience.
Understanding ISO 13485
Instructor: Meena Chettiar
Product ID: 500883

Why Should you Attend:
Attend this 75 minutes webinar to remain complaint to the medical device regulatory requirements for your global customers. The areas covered in this session are:
  • History behind the changes being introduced to ISO 13485 in 2015.
  • What are the quality system elements that are being changed?
  • What does this mean to your established quality system under ISO 13485: 2003 and 21 FR 820?
  • A step by step approach to becoming compliant to the new regulatory requirements will be covered by the experience speaker who has been following through every step of this global process.
  • You will also learn about the timelines to focus on and quickly switch gears to the elevated regulatory expectations under ISO 13485: 2015.
Objectives of the Presentation:
The key learning objectives of the presentation are:
  • What is in store for currently marketed medical devices when ISO 13485: 2015 gets launched?
  • Which areas are being revamped under ISO 13485: 2015?
  • Where does one begin?
  • What sort of gap analysis is a must?
  • When is your quality system expected to be completely switched over to cater to the changes being introduced?
Who can Benefit:
  • Quality and Regulatory Managers
  • Quality Assurance
  • Supplier Management and auditing professionals in the medical device or medical device-pharmaceutical industry quality professionals all across the world.
  • ISO 13485: 2015, Medical device regulations, Quality system for medical devices
$375
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.

Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has worked as Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer, a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has performed mock QSIT Audits and has responded to several FDA 483s.

Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, Canada, Puerto Rico and Costa Rica. Meena is the Chair elect for MNASQ (American Society for Quality) this year. Meena is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).

Meena has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana and is very passionate about Installation and growth of Quality Systems in general.
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