experience pdt: a global product development firm
DESCRIPTION
PDT is a global product development firm. We provide turnkey product design and development services in the medical, consumer and defense sectors. For more information, please visit: http://www.pdt.com.TRANSCRIPT
PDT's New World HeadquatersOne Corporate Drive Suite 110
Lake Zurich, Illinois 60047
"Informed Innovation ®"
Introduction
This book focuses on a selection of programs that the global team at Product Development Technologies (PDT) have had the honor to collaborate on since being established in 1995.
As one of the few product development consultancies awarded ISO 9001, ISO 13485 and ITAR certifications, PDT seamlessly integrates a smooth process driven path to each program ensuring a smooth and successful realization across all industries.
PRODUCT DEVELOPMENT PROCESS
PDT’s process meets the following standards:
• ISO 13485 certified compliance• FDA 21 CFR 820.30 requirements• Risk management and design control from concept through validation
• Hazard identification and mitigation• Risk Analysis / Trace-ability matrix• DHF (design history files) Declaration of Conformity
• 60601 medical standard (CE)• UL 2601• FDA 510K requirements
ISO
13485CERTIFIED
ISO
9001CERTIFIED
Contact
Published and sent to you by your local PDT studio,
PDTOne Corporate Drive, Suite 110Lake Zurich, Illinois, 60047
p 847 821 3000f 847 821 3020e [email protected] http://www.pdt.com