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
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.
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.