Harvey Rudolph
President at Retired | Bethesda, Maryland, United States
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Harvey Rudolph, now retired, has left an indelible mark on the field of risk management within the medical device industry. With a robust background in consulting, assessment, and training specifically focused on ISO 14971, he has been instrumental in shaping the standards that govern risk management practices. His extensive experience in risk management auditing and consulting has equipped him with a deep understanding of the complexities involved in ensuring compliance and safety in medical devices.
As co-chair of the US Technical Advisory Group (TAG) for the Joint Working Group on risk management, Harvey played a pivotal role in the development and co-authorship of ISO 14971 from 1996 to 2013. His contributions to this critical standard have helped organizations worldwide enhance their risk management systems, ensuring that safety and efficacy are prioritized throughout the product lifecycle.
Throughout his career, Harvey has assessed numerous risk management systems, establishing frameworks that align with ISO 13485 and Good Manufacturing Practices (GMP). His expertise extends to Corrective and Preventive Action (CAPA) processes, validation, and verification (V&V), making him a sought-after leader in quality assurance. Harvey’s ability to lead cross-functional teams has fostered collaboration and innovation in the industry, enabling organizations to navigate the complexities of regulatory compliance effectively.
As he reflects on his career, Harvey extends his best wishes to all his colleagues and peers, emphasizing the importance of continued health and prosperity in the ever-evolving landscape of medical device regulation and quality management. His legacy continues to inspire those dedicated to advancing safety and quality in healthcare.
President at Retired in February 2015 to Present
Principle Consultant at HRRM, LLC in June 2007 to February 2015
Senior Advisor to the Health Sciences Division at Underwriters Laboratories (UL- UL International GmbH) in June 2007 to July 2013
Global Program Manager--Medical at Underwriters Laboratories, Inc. in October 2000 to June 2007
Deputy Director, OST at CDRH/FDA in November 1975 to September 2000
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FDA
Medical Devices
ISO 14971
Risk Management
UL
EN/ISO 14971:2012
ISO/TR 24971
Regulatory Requirements
Design Control
ISO 13485
Auditing
CAPA
V&V
Validation
GMP
Quality Assurance
Cross-functional Team Leadership
Quality Management
Corrective and Preventive Action (CAPA)
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Discover more about RetiredWhat is Harvey Rudolph email address?
Email Harvey Rudolph at [email protected]. This email is the most updated Harvey Rudolph email found in 2026.
What is Harvey Rudolph phone number?
Harvey Rudolph phone number is +12024120763.
How to contact Harvey Rudolph?
To contact Harvey Rudolph send an email to [email protected]. If you want to call Harvey Rudolph try calling on +12024120763. (updated on October 30, 2024)
What company does Harvey Rudolph work for?
Harvey Rudolph works for Retired
What is Harvey Rudolph's role at Retired?
Harvey Rudolph is President
What industry does Harvey Rudolph work in?
Harvey Rudolph works in the International Trade And Development industry.
Harvey Rudolph Email Addresses
Harvey Rudolph Phone Numbers
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