Harmonization of standards and regulations should be addressed through collaboration of government and private sector

Comprehensive lifecycle services to mitigate global risk for the health sciences

Anil N. Patel P.E.

Abel Torres

Second WHO Global Forum on Medical Devices

Geneva, Switzerland

22 to 24 November 2013

What We Do…

- Simply put, we provide Testing Certification and Regulatory

services for assessing conformance to:

(1) quality and risk management system requirements

(2) device safety and effectiveness requirements

- Rely on many international standards available to carry out the

conformity assessment process

- We provide global and local access to our technical expertise

- Our partnership with companies can span the product lifecycle

- We help clients understand the requirements

Collaboration

Convergence in regulatory practices and standards

harmonization – helps ensures safety and effectiveness

Third Party Solutions

• Testing, Certification,• Validation, • Supplier management,• Conformity

Complaints,

Fines,

Recalls

Solutions

Safety, Quality,

Usability,

Interoperability

Brand,

Reputation,

Compliance

Thank You

Anil N. Patel

Anil.N.Patel@ul.com

Abel Torres

Abel.Torres@ul.com