Understanding FDA Design Verification and Validation Requirements for Medical Devices

This webinar will help you understand specific product verification and validation requirements for medical devices to comply with ISO 13485: 2016 and FDA quality system regulations. It will focus on the topics such as product development process, traceability and risk management at all stages, design outputs and documentation in DMR and DHR, design verification and design validation activity cycles and more.

Recorded Version Only

(PPT + Recorded Streaming Link)

$299.00
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rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Jan-2018

CD or USB Drive Only

(PPT + Recorded Training File)

$399.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Areas Covered in the Webinar:
  • Product development process overview for design control management in the medical device industry for introducing a new product and sustaining your product design throughout the product life cycle.
  • Overview of applicable design verification and validation requirements for your globally distributed medical devices.
  • Testing requirements including the pertinent ISO guidelines to fulfill the key acceptance and evaluation criteria for your products at the different stages of its evolution and its life history.
  • Translation of user requirements into design inputs and role of testing and regulatory requirements.
  • Fulfilling critical to customer and critical to quality requirements.
  • Design verification and design validation activity cycles.
  • Traceability and risk management at all stages.
  • Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records).
  • Proof for how design outputs meet functional and operational requirements of your device.
  • Compatibility of the design with components and other accessories including software, packaging and labelling management.
  • Criteria for establishing test requirements to fulfil acceptance criteria for final products after validation and into the manufacturing cycle.
  • Design reviews at major decision points to withstand regulatory scrutiny.
  • How are changes and their effects controlled and documented during the device life cycle?
  • Key concepts for translating your device customer requirements into design inputs, outputs and fulfill product compliance/ audit requirements throughout your product life cycle.
Who Will Benefit:
  • R & D , Quality and Manufacturing Engineers
  • QC/QA Personnel
  • Test Engineers
  • Regulatory Professionals
  • Engineering managers and personnel
Instructor Profile:
Meena Chettiar Meena Chettiar

Principal Quality Engineer, Freudenberg Medical

Meena Chettiar is currently working as a Principal Product Development Quality engineer at Freudenberg Medical in Minnesota, USA. Meena has worked in several capacities over the past 20 years in several high level Quality and Regulatory Management positions at pharmaceutical and medical device companies such as ProMed Pharma, Covidien, Teva Pharmaceuticals and NAMSA. She has also worked as QC lab supervisor at Land O’ Lakes in Minnesota and for Agriculture and Health Canada in several technical capacities for about 10 years.

Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, India, Costa Rica, Mexico and Puerto Rico. She is a senior member of ASQ (American Society for Quality) and 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).She has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and has been an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota since 2013. She is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.

Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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