Christopher Holscher
Quality and Regulatory Compliance Consultant at Red Edge Medical Device Consulting | San Jose, California, United States
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Christopher Holscher is a distinguished Quality and Regulatory Compliance Consultant at Red Edge Medical Device Consulting, bringing over three decades of extensive experience in the medical device industry. His expertise spans both domestic and international markets, with a strong focus on Quality Assurance and Regulatory Compliance. As a certified Quality Auditor and ISO 13485 Lead Auditor, Christopher is well-versed in the intricacies of medical device regulations and quality systems, ensuring that products not only meet but exceed compliance standards.
At Red Edge, Christopher plays a pivotal role in guiding clients through the complexities of the product development cycle, particularly in the realms of disposables, electromechanical devices, and implantable technologies. His deep understanding of ISO 13485 standards enables him to implement robust quality management systems that enhance operational efficiency and product safety. Christopher is adept at conducting thorough validation processes, including Verification and Validation (V&V), to ensure that medical devices are reliable and effective.
Key projects under his leadership often involve the development and execution of Corrective and Preventive Action (CAPA) plans, ensuring that any non-conformities are addressed proactively. His proficiency in navigating U.S. Title 21 CFR Part 11 regulations further solidifies his capability to assist organizations in maintaining compliance while fostering innovation. With a proven track record in project management and a commitment to excellence, Christopher Holscher continues to be a trusted advisor in the medical device sector, helping companies achieve their regulatory goals while enhancing product quality and patient safety.
Quality and Regulatory Compliance Consultant at Red Edge Medical Device Consulting in January 2003 to Present
Vice President Quality Assurance at Ceribell │ AI-Powered Point-of-Care EEG in September 2024 to Present
Sr. Director Quality and Regulatory Affairs at Ceribell │ AI-Powered Point-of-Care EEG in July 2020 to November 2024
QA/RA Consultant at LAAx, Inc./Maquet in January 2012 to January 2016
Director, Quality Assurance at Tenaxis Medical, Inc. in June 2009 to May 2010
Director, Quality Systems at Cardica, Inc. in December 2005 to April 2009
Director, QA/RA/Clinical at Solarant Medical, Inc. in February 2004 to October 2005
Manager, Quality Systems at SURx, Inc. in December 1999 to January 2004
Manager, Quality Assurance at Aesculap in August 1998 to November 1999
Senior Quality Specialist at Cardima, Inc. in August 1997 to August 1998
Manager, Complaints and MDR's at McGhan Medical in January 1987 to January 1997
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Humboldt State University, BA, October 1981 to October 1984
Santa Monica College, October 1979 to October 1981
Santa Monica High School, Yes, October 1976 to October 1979
St.Paul the Apostle, October 1973 to October 1975
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Quality Management
Auditing
FDA
ISO 13485
Medical Devices
Quality System
Cross-functional Team Leadership
Regulatory Affairs
CAPA
Validation
V&V
Project Management
Manufacturing
Quality Assurance
Design Control
GMP
21 CFR Part 11
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Product Development
U.S. Title 21 CFR Part 11 Regulation
Verification and Validation (V&V)
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What is Christopher Holscher email address?
Email Christopher Holscher at [email protected] and [email protected]. This email is the most updated Christopher Holscher's email found in 2026.
How to contact Christopher Holscher?
To contact Christopher Holscher send an email to [email protected] or [email protected]. (updated on September 02, 2024)
What company does Christopher Holscher work for?
Christopher Holscher works for Red Edge Medical Device Consulting
What is Christopher Holscher's role at Red Edge Medical Device Consulting?
Christopher Holscher is Quality and Regulatory Compliance Consultant
What is Christopher Holscher's Phone Number?
Christopher Holscher's phone (213) ***-*516
What industry does Christopher Holscher work in?
Christopher Holscher works in the Medical Devices industry.
Christopher Holscher Email Addresses
Christopher Holscher Phone Numbers
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