When Patient Safety Matters, Sterility Assurance Matters More Than Ever
2026 is the year. The Medtech industry is moving — together — toward a more efficient, resilient, and technically rigorous sterility assurance supplier oversight model. Don’t stay on the sidelines. Jump in and help lead the future of MedTech quality.
In a post-pandemic world, sterilization is one of the highest-risk, highest-scrutiny processes in the medical device lifecycle. With increasing regulatory pressure, supply chain complexity, and heightened public health expectations, Medical Device OEMs require a consistent, industry-accepted method to verify sterilization and sterilization-related laboratory testing quality, competency, and compliance.
The MedAccred® Sterility Assurance Supplier Oversight Program is the medical device industry’s most trusted way to verify sterility assurance, reduce risk, and strengthen supplier quality. Backed by findings from the MDIC Pilot Study with participation from FDA, the MedAccred program's technical process and QMS audits deliver unmatched technical rigor, consistency, and visibility across the sterilization supply chain.
Watch video to learn more about the MedAccred® Sterilization Program
MedAccred® Fee Structure
Get involved with the MedAccred® Program to provide unmatched technical rigor, consistency, and visibility across your sterilization supply chain.
Starting at $15,000 per year Full MedAccred access for OEMs accountable for critical process conformance, including audit reports, metrics, and Task Group voting rights. Starting at $3,000 per year 
Small Device Manufacturer Subscriber (<$250M revenue) Cost‑effective access for smaller OEMs to MedAccred data, technical resources, and open‑meeting participation supporting supplier oversight and compliance. Starting at $7,500 per year 
Contract Manufacturer Subscriber Designed for contract manufacturers managing sub‑tier suppliers, with access to audit reports, program metrics, Task Group participation, and approvals. Starting at $750 per year 
General Industry Subscriber Entry‑level visibility for regulators, associations, and ecosystem partners seeking MedAccred data, metrics, and program insights without governance roles.
MedAccred Subscriber Fee Structure
TIER 1
Access: All TechTIER 2
Access: 2 TechTIER 3
Access: 1 TechOEM
(Revenue > $250M)$50,000 $30,000 $15,000 Contract Manufacturer $25,000 $15,000 $7,500 Small OEM
(Revenue < $250M)$10,000 $6,000 $3,000 General Industry $2,500 $1,500 $750 A Scalable Path Forward
MedAccred’s Tiered Subscription Model allows organizations to engage at the level that aligns with their current needs, offering flexible entry points without sacrificing technical rigor or industry credibility. From early engagement to comprehensive supply chain oversight, organizations can participate at the level that makes sense today and expand as priorities, oversight needs, and risk profiles evolve. Available technoogies:
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Sterlization
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Sterile Device Packaging
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Electronics
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Plastics
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Welding
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Heat Treating
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Resources for You
What is Different about the MedAccred Approach?
Unlike broad QMS audits, the MedAccred program dives into critical manufacturing processes ensuring compliance with stringent standards (ISO 13485, ISO 11135/11137, etc.) and reducing risk across the supply chain. All audits are conducted by a expert MedAccred auditor.
Sterilization & Laboratory Testing Accreditation
Strengthening Sterility Assurance from Process to Validation
MedAccred® provides independent, expert-driven oversight of both sterilization processes and the laboratory testing that supports sterility assurance. By combining these critical areas within a single accreditation model, MedAccred helps close long-standing gaps in oversight, reduce redundant audits, and improve confidence across the supply chain.
Closing the Oversight Gap in Sterility Assurance
MedAccred accreditation evaluates conformance to key sterilization standards, including ethylene oxide (ISO 11135) and radiation sterilization (ISO 11137), along with quality management system requirements aligned to ISO 13485 and 21 CFR Part 820.
Audit criteria are developed and governed by the MedAccred Sterilization Task Group—industry experts representing OEMs, contract sterilizers, and suppliers—ensuring a consistent, technically rigorous approach.
Integrated Laboratory Testing
To strengthen validation and release decisions, MedAccred includes Sterilization Laboratory Testing within its accreditation scope (AC8113/3), covering:
- Sterility testing and bioburden recovery
- Biological indicator testing
- Bacterial endotoxin testing, including validation and inhibition/enhancement studies
- Media preparation, quality control, and microorganism management
- Equipment qualification and calibration
- Cleanroom controls and environmental monitoring
Criteria incorporate ISO 11737, ISO 11138 series, and harmonized pharmacopeia. For laboratories not accredited to ISO/IEC 17025, applicable requirements are included within the audit.
How to Get Started with Sterilization Audits and Accreditation
Connect with our team to discuss readiness, requirements, or next steps toward MedAccred Sterilization Accreditation or Laboratory Testing Accreditation.
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Contact Information
Email: MedAccred@p-r-i.org
Telephone
- Americas: +1 (0) 724 772 1616
- Asia: +86 (0) 10 6463 6008
- Europe: +44 (0) 870 350 5011
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