AdvaMed Standards
Overview
AdvaMed is an ANSI-accredited Standards Development Organization (SDO), convening stakeholders across the global medical technology ecosystem to create consensus-driven standards. These standards form the foundation for safe, effective, and innovative medtech — building trust across patients, providers, regulators, and innovators worldwide.
Our Role as an Accredited Standards Developer
AdvaMed is proud to be accredited by the American National Standards Institute (ANSI). This accreditation ensures that our standards process is transparent, consensus-based, and inclusive of all relevant stakeholders. Every project follows strict procedures that balance the interests of manufacturers, users, regulators, and the public — giving our standards authority, credibility, and impact.
Why Standards Matter
Standards are the backbone of trust in medtech. They:
– Drive patient safety and product quality
– Streamline regulatory pathways and accelerate market access
– Enable interoperability across devices, platforms, and health systems
– Provide a common language for global markets
– Reduce uncertainty for innovators and healthcare providers
Why It Matters for Members
Participating in AdvaMed’s standards initiatives provides members with unique opportunities to:
– Influence the direction of industry standards and policies
– Gain early insight into emerging regulatory and technical requirements
– Collaborate with peers, regulators, and international stakeholders
– Demonstrate leadership in advancing safe, effective, and innovative technologies
Engagement in standards isn’t just about compliance — it’s about shaping the future of medtech.
Global Impact
Medical technology knows no borders. AdvaMed standards:
- Support international market access for member companies
- Align with global regulatory frameworks and partner organizations
- Provide a common language that drives interoperability across devices, platforms, and health systems worldwide
By working with stakeholders in 40+ countries, we help ensure that standards developed through AdvaMed reach patients everywhere.
Submit a Proposal
Have an idea that could move medtech forward? AdvaMed invites members and partners across the ecosystem to propose new or updated standards that:
- Advance innovation
- Improve quality
- Build global trust
To submit, complete a short form describing your proposal, its relevance to medical technology, and its potential impact.
What We Are Working On
AdvaMed collaborates with industry leaders, regulators, and global stakeholders on priority projects that set the path for safe, effective, and innovative technologies.
- Identifying standards setting opportunities across MedTech
- Model patient notification language regarding use of AI in healthcare
- Digital health data access standards
- Medical imaging standards
Get Involved
Shape the future of medtech standards. Whether you’re a manufacturer, a user, or represent general interest, your perspective is vital.
Apply to participate in an ongoing standards project.
Frequently Asked Questions
Who can propose a new standard?
Any AdvaMed member, partner, or stakeholder with an idea to advance medtech can submit a proposal.
Do I need to be a member to participate?
Non-members may be considered for participation, but AdvaMed members receive priority and additional benefits.
How long does the process take?
Timelines vary depending on the complexity of the standard and stakeholder input. AdvaMed staff provide guidance at every step.
Where do I start?
Submit a proposal or apply to participate in an existing project using the forms above
Become an AdvaMed® Member
Join over 500 medical technology companies as a member of one of the most effective trade associations in Washington, D.C.