Certification to ISO 13485 demonstrates Previon’s commitment to quality
Yorba Linda, CA 2022 – Previon has achieved ISO 13485 certification from NSF-ISR, an NSF company. The ISO 13485 standard is the quality management systems standard for the medical device industry.
Based on the ISO 9001 process approach to quality management, the primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization.
Previon is the single source for preventive health test kitting, kit logistics, and healthcare communications. We provide integrated consulting and best practice solutions for laboratories, healthcare organizations and payers, in “at-home test kit” services. We are a leader in the industry with over 10 years in the “Direct to Patient” and “Bulk” customized health test kit expertise, technology, and services. Previon has helped healthcare organizations adopt processes that close care gaps, meet regulations, and drive continuous quality improvement.
“We are delighted to announce this milestone attainment of the ISO-13485 certification. It is a fantastic achievement not only to be certified but also recognized for our standard in quality management. As we continue to grow and effectively provide solutions for health care organizations, we are committed to helping our customers close care-gaps and focus on a better future. This ISO-13485 achievement embodies the high standard and quality we strive for at Previon.” -Joel Luce, CEO
By earning ISO 13485 certification through NSF-ISR, Previon demonstrates a commitment to continual improvement of either manufacturing or service processes helping to ensure the safety and effectiveness of medical devices.
Learn more about Previon
Dedicated to empowering organizations with cost-effective internal tools that enable high-quality care for patients and health plan members, Previon added preventive health test kitting to our suite of solutions. Our unique approach to packaging and mailing a proprietary colorectal cancer (CRC) FIT kit was awarded a patent that we leverage today to optimize kit campaigns for a variety of direct-to-patient programs.
As Previon continues to evolve to help healthcare organizations overcome disruption, we remain focused on filling critical gaps in the way teams connect with each other and the communities they serve. By blending digital and traditional methods, we encourage payers, pharmacy benefit managers, and employers to lead with customized, economic engagement strategies that place personal care in the hands of individuals.
NSF is an independent, global organization that facilitates standards development, and tests and certifies products for the food, water, health sciences and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With operations in 180 countries, NSF is a Pan American Health Organization/World Health Organization Collaborating Centre on Water Quality, Food Safety, and Medical Device Safety.
NSF International Strategic Registrations (NSF-ISR) offers a comprehensive portfolio of management systems registration solutions to meet the demands of the global marketplace (nsf-isr.org). NSF-ISR is the largest automotive registrar in North America and is recognized by the International Automotive Task Force (IATF) to provide IATF 16949 registrations in the automotive sector. NSF-ISR also provides registrations for the following programs: ISO 9001, ISO 14001, ISO 45001, ISO 27001, AS 9100/10/20, ISO 13485, ISO 20000-1, Responsible Care (RC) 14001 and Responsible Care Management Systems (RCMS), as well as greenhouse gas verification/validation.