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When Patient Safety Matters, Sterilization Accreditation Matters More Than Ever
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, OEMs require a consistent, industry-managed way to verify sterilization quality, competency, and compliance.
Industry-Backed. FDA-Informed. Supplier-Strengthening.
MedAccred Sterilization Accreditation 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 observers, the MedAccred program's process-level audits deliver unmatched technical rigor, consistency, and visibility across the sterilization supply chain.
MedAccred Subscriber Fee Structure Why Companies Choose the MedAccred program
- Validated through the MDIC pilot as robust, comprehensive, and suitable for regulatory use
- Reduces redundant OEM audits and strengthens purchasing controls
- Ensures compliance to ISO 11135, ISO 11137, ISO 13485, 21 CFR 820, and global sterilization requirements
- Conducted by industry-recognized sterilization SMEs
- Trusted by leading OEMs including BD, Boston Scientific, Edwards, Medtronic, Philips, Stryker, and Gore
Why MedAccred® Sterilization Audit and Accreditation?
Unlike broad QMS audits, MedAccred dives into critical manufacturing processes—such as sterilization, plastics, and electronics—ensuring compliance with stringent standards (ISO 13485, ISO 11135/11137, etc.) and reducing risk across the supply chain.
Benefits:-
Technical Rigor: In-depth audits by SMEs, consistent with global standards, supplement internal expertise and reduce variability.
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Patient Safety: Strengthens process control and compliance, minimizing defects and safeguarding end-user health.
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Cost Efficiency: Cuts redundant audits, reallocates resources, and accelerates supplier approvals, reducing audit burden and associated travel costs.
Learn more about the MedAccred program.
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Sterilization Laboratory Testing Accreditation
Closing the Oversight Gap in Sterility Assurance
Establishing a safe, validated sterilization process requires extensive and reliable laboratory testing. To close this long-standing industry gap, MedAccred expanded and includes sterilization laboratory testing within its accreditation scope, guided by audit criteria AC8113/3.
This expansion strengthens sterility assurance across:
- Test of Sterility and Bioburden Recovery
- Biological Indicator Testing
- Endotoxin Testing, Validation & Inhibition/Enhancement Studies
- Media Preparation, QC, and Microorganism Maintenance
- Equipment Qualification & Calibration
- Clean Room Controls & Environmental Monitoring
The criteria incorporates compendial requirements and standards including ISO 11737-1/2/3, ISO 11138 series, and harmonized pharmacopeia.
For labs not already accredited to ISO 17025, the checklist includes those requirements as well.Lab Testing Accreditation Matters
- Ensures consistent, high-quality sterility testing
- Reduces risks tied to laboratory variability
- Increases credibility with OEM customers
- Eliminates redundant customer audits
- Accelerates product development timelines
- Strengthens supply chain transparency and compliance
Participating labs include Steris Lab, TUV-SÜD, W.L. Gore, Zimmer Biomet, and others.
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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