AdvaMed Achieves National Accreditor’s Endorsement to Develop Medical Device Standards

The MedTech Association Will Begin Developing Standards for Medical Imaging Devices, a "New Milestone" for AdvaMed

WASHINGTON - AdvaMed, the Medtech Association, announced today that it has received accreditation from the premier American National Standards Institute (ANSI) to develop industry standards for medical device innovation. As an ANSI-accredited organization, AdvaMed will begin by developing standards for medical imaging technologies, including applications important to all of medtech, such as cyber security and artificial intelligence.

"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," said Scott Whitaker, president and CEO of AdvaMed. "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," said Patrick Hope, executive director of AdvaMed's Imaging Division. "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."

Official industry standards establish guidelines, specifications, and/or requirements for medical products, services, processes, or materials. These new AdvaMed-driven standards will:

• Help markets operate smoothly by establishing trust.
• Protect consumers by ensuring products are safe, effective, durable, and equitable.
• Enable "interoperability," meaning technologies/devices from different manufacturers will be able to safely and effectively communicate with each other.
• Provide a common language to measure and evaluate performance.
• Help facilitate trade by providing a framework for achieving economies, efficiencies, and interoperability.
• Establish, measure, and assure quality and predictability.

ANSI accreditation signifies that AdvaMed's standards development processes meet the highest national and international benchmarks for transparency, due process, and stakeholder engagement. ANSI accreditation confirms alignment with many governmental bodies that require ANSI accreditation to comply with licensing laws. Lastly, because ANSI is the official U.S. representative to the International Organization for Standardization (ISO), ANSI accreditation for medical devices ensures that U.S. standards align with international regulations, facilitating global market access and enhancing safety and efficacy across borders.

The accreditation process involved a comprehensive review of AdvaMed's procedures for developing and maintaining industry standards, ensuring they are both rigorous and inclusive. AdvaMed has a strong history of engaging on U.S. and global standards policy issues. With ANSI's endorsement, AdvaMed is better equipped to continue this collaboration with industry stakeholders, regulatory bodies, and other organizations to shape the future of medical technology.

As the medical technology sector continues to evolve, AdvaMed remains committed to promoting best practices, fostering innovation, and ensuring that medical devices meet the highest standards of safety and efficacy. ANSI accreditation strengthens AdvaMed's role as a leader in setting industry benchmarks and supporting its members by bringing groundbreaking technologies to market. In 2023, AdvaMed celebrated the 30^th anniversary of its Code of Ethics, which provides medical technology companies with guidance on ethical interactions and relationships with health care professionals, based on the cornerstone values of innovation, education, integrity, respect, responsibility, and transparency.

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