Key Considerations in Verification & Validation of Medical Devices

Instructor: Mercedes Massana
Product ID: 701772
  • Duration: 60 Min
This medical device verification and validation training will dissect some of the FDA 483 observations related to design verification and design validation, and provide key information on how they can be prevented.

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
Last Recorded Date: Aug-2015

Training CD / USB Drive

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

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Why Should You Attend:

Verification and Validation are required as part of 21 CFR § 820.30. A review of recent FDA 483 observations indicates that a number of observations documented deficiencies in design verification and design validation. By learning from other firm’s mistakes and instituting a sound verification & validation strategy, along with proper verification and validation planning, these types of observations can be prevented.

There is a wide variation of how the medical device industry manages requirements. This presentation will cover a requirements management approach consistent with the CMMi Requirements Management KPA, that helps companies meet Design Control requirements. The presentation will show how the Requirements Management Specific Goals satisfy Design Control requirements. Specific Goals to be reviewed are:

We will cover key considerations and best practices when performing design verification and design validation of medical devices.It is intended to give the attendees key knowledge in areas that are repeatedly cited in FDA 483s. The presentation will cover verification and validation related observations including,

  • Failure to conduct design validation using production units or their equivalents
  • Failure of the verification testing to confirm that the design outputs meet the design input requirements
  • Failure to ensure that design testing is conducted under actual or simulated use conditions
  • Failure to maintain written design testing results

Areas Covered in the Webinar:

  • How to properly plan Verification and Validation activities.
  • Verification & Validation testing throughout the product life cycle.
  • How to determine sample sizes needed for testing.
  • What is appropriate objective evidence.
  • How to perform regression analysis.
  • What is meant by Production Equivalence.
  • How do we validate test methods.
  • Special considerations for software based products.

Who Will Benefit:

This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include:

  • Systems engineers responsible for developing requirements
  • Software developers
  • Test Engineers
  • Quality System auditors
  • Engineering managers and personnel
Instructor Profile:
Mercedes Massana

Mercedes Massana
Founder & CEO, MDM Engineering Consultants

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

Follow us :
Biocompatibility Testing for Medical Devices
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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. ComplianceOnline 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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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