Learning Marketplace

Validation and Verification, are you clear on the requirements?

Verification and Validation are words often quoted within medical devices, but do you really understand the definition of the two separate words, and are you confident that you are meeting the regulatory requirements in this area?

Join the webinar to hear from two experienced BSI ISO 13485 auditors about the importance of validation and verification in your quality management system, product design and manufacturing.

The publication of the new ISO 13485:2016 has increased the requirements and focus in this area, and we will cover the additional obligations you will need to meet to achieve ISO 13485:2016.

This free BSI webinar will cover:

  • Descriptions and definitions
  • Basic types, device and process
  • Use of Statistics
  • ISO 13485:2016 requirements
  • Examples of special processes and software.

Presenters

Ivan Whelan is Head of Assessment Delivery 13485 EMEA BSI Medical Devices. Ivan has over 15 years auditing experience and 17 years industry experience working with plastics, pharmaceuticals, biotechnology, clinical microbiology and medical devices in a number of management and product specialist roles.

Richard Tully is the technical lead for ISO 13485 EMEA, and is a Scheme Manager and Product Expert in the BSI Active Devices team. Richard has worked for BSI for five years, liaising with clients to manage their certification and providing assessment against the requirements of ISO 13485.