Big Win for AdvaMed: National Accreditor Approves New Device Standards

AdvaMed, the leading Medtech Association, has just been accredited by the prestigious American National Standards Institute (ANSI) to set industry standards for advancements in medical devices. With this new ANSI accreditation, AdvaMed will kick off its efforts by establishing standards for medical imaging technologies. This includes crucial areas for the medtech sector, such as cybersecurity and artificial intelligence.

Scott Whitaker, president and CEO of AdvaMed, said in a statement, “Achieving ANSI accreditation is a testament to AdvaMed’s long history of advocating for and upholding the highest standards on behalf of the patients we serve. And this new milestone further demonstrates that AdvaMed is the place to be for medtech companies seeking not only to impact policy around the world but who want to ensure their companies and technologies are in the best possible position to succeed. By adhering to ANSI’s procedures, we can more effectively advocate for policies that support industry advancement and improve patient outcomes.”

“Earning ANSI accreditation is an important milestone for AdvaMed in its inaugural year representing the medical imaging industry. AdvaMed’s ANSI-accredited standards will help ensure that the guidelines and specifications we develop reflect the consensus of imaging experts, aligning the practices and technologies of different manufacturers to foster uniformity and higher quality across the industry,” states Patrick Hope, executive director of AdvaMed’s Imaging Division. 

Official industry standards provide crucial benchmarks for medical products, services, processes, or materials by outlining essential guidelines and specifications. The new AdvaMed-driven standards will enhance market operations by building trust, protect consumers through ensuring product safety, effectiveness, durability, and fairness, and promote "interoperability," allowing devices from different manufacturers to work together seamlessly. They will also establish a common framework for evaluating and measuring performance, facilitate trade by offering a structured approach to achieving efficiency and interoperability, and ensure consistent quality and predictability.

ANSI accreditation signifies that AdvaMed's processes for developing standards adhere to the highest national and international standards for transparency, due process, and stakeholder involvement. This endorsement not only confirms alignment with various governmental requirements but also ensures that U.S. standards are consistent with international regulations through ANSI’s role as the official U.S. representative to the International Organization for Standardization (ISO). This alignment facilitates global market access and promotes safety and efficacy across borders.

The accreditation process included a thorough evaluation of AdvaMed’s procedures for creating and maintaining industry standards, verifying their rigor and inclusiveness. AdvaMed’s strong track record in addressing both U.S. and global standards policy issues is further strengthened by ANSI’s endorsement. This support enhances AdvaMed’s ability to collaborate with industry stakeholders, regulatory bodies, and other organizations, shaping the future of medical technology.

As the medical technology industry advances, AdvaMed is dedicated to advancing best practices, encouraging innovation, and upholding the highest safety and efficacy standards for medical devices. With ANSI accreditation, AdvaMed solidifies its position as a leading force in establishing industry standards and assisting members in introducing cutting-edge technologies. In 2023, AdvaMed marked the 30th anniversary of its Code of Ethics, offering medical technology companies essential guidance on ethical conduct and relationships with healthcare professionals, rooted in the core values of innovation, education, integrity, respect, responsibility, and transparency.