
China GMP and ISO 13485: A Side-by-Side Comparison
China GMP and ISO 13485: A Side-by-Side Comparison
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On behalf of our members, AdvaMed® works on countless fronts to ensure patients have timely access to life-changing technologies. Find out more about our top policy issues.

China GMP and ISO 13485: A Side-by-Side Comparison

AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions…

AdvaMed outlines recommendations to ensure EPA’s proposed ethylene oxide (EtO) emissions standards protect public health while maintaining access to life-saving medtech.

Explore AdvaMed®’s Q1 2026 report on medtech policy, regulatory trends, reimbursement, and advocacy driving innovation and patient access.

AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.

Explore AdvaMed®’s key achievements and milestones in 2025 on behalf of our member companies and the patients they serve.

China GMP and ISO 13485: A Side-by-Side Comparison

AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions…

AdvaMed outlines recommendations to ensure EPA’s proposed ethylene oxide (EtO) emissions standards protect public health while maintaining access to life-saving medtech.

Explore AdvaMed®’s Q1 2026 report on medtech policy, regulatory trends, reimbursement, and advocacy driving innovation and patient access.
AdvaMed® members have access to our full library of industry resources.

This October 18–21, innovators, executives, investors, policymakers, clinicians, entrepreneurs, and industry partners will gather in Boston for our industry’s premier event. I hope your organization is making plans to join…

WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the largest trade association representing medtech innovators, posted his statement on LinkedIn regarding the nomination of Chris Klomp as deputy secretary of the…
GHENT, BELGIUM — XEOS, a medical technology company advancing intraoperative molecular imaging, today announced the publication of the BrIMA (Breast cancer Intraoperative Margin Assessment) study in JAMA Surgery, world’s leading…

Millions of Americans have the neurological condition essential tremor. Often, that means their hand shakes so badly, they can’t hold a pen, fork, or glass of water. Every activity of…
Washington, D.C.—AdvaMed, the largest trade association representing medtech innovators, announced today it is a WTOP News Top Workplaces 2026 award winner in the Washington, D.C., region and received five Culture…
EAGAN, Minn. – June 9, 2026 – Sonex Health, Inc. (Sonex Health) and The Institute of Advanced Ultrasound Guided Procedures today announced publication of six-month data demonstrating the safety and efficacy…

Millions of patients’ lives are improved every day because of advancements in medical technology. But too often, gaps in coverage and access prevent patients from benefiting from the safe, effective,…
BOSTON, MA, UNITED STATES, May 26, 2026 /EINPresswire.com/ — UltraSight™, a leader in AI-guided cardiac imaging, today announced publication of a multicenter peer-reviewed study in European Heart Journal – Digital…

The AdvaMed Medtech Compliance Workshop is a forum designed specifically for medtech compliance leaders and legal and other professionals with health care compliance responsibilities.
BOSTON, MA, UNITED STATES, May 19, 2026 /EINPresswire.com/ — UltraSight™, a leader in AI-guided cardiac imaging, today announced the appointment of Rick Geoffrion as Chairman of the Board. Mr. Geoffrion…
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