harmonization of standards and regulations should be ... · emc — iec 60601-1-2 ansi / ul 60601...
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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
