Certification
ISO 13485 Certified CDMOs
Compare CDMOs with ISO 13485 certification for medical device and combination product manufacturing. Filter by device type and manufacturing capabilities.
857 companies listed
About ISO 13485 in Pharmaceutical Manufacturing
ISO 13485 is the quality management system standard specific to medical devices. In the CDMO context, it applies to manufacturers of combination products -- drug-device combinations such as pre-filled syringes, autoinjectors, metered-dose inhalers, and transdermal patches. CDMOs manufacturing these products must comply with both pharmaceutical GMP and device quality system requirements.
The combination product market is growing rapidly, driven by the shift toward self-administered biologics (prefilled syringes, autoinjectors) and inhaled therapies. CDMOs with ISO 13485 certification can handle the dual regulatory burden of drug GMP and device quality systems, which are governed by different regulatory frameworks (21 CFR Part 211 for drugs, 21 CFR Part 820 for devices in the US).
Companies (857)
7bridges (the7bridges.com)
United Kingdom
7bridges (the7bridges.com) is a pharmaceutical CDMO offering comprehensive services.
Small Molecule APISmall Molecule Drug ProductOral Solid Dose
AEQUILIBRIUM PHARMA S.r.l.
Italy
AEQUILIBRIUM PHARMA S.r.l. is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Frequently Asked Questions
When is ISO 13485 needed for pharmaceutical manufacturing?+
ISO 13485 is needed when the CDMO manufactures combination products -- products that combine a drug component with a device component. Examples: prefilled syringes, autoinjectors, pen injectors, metered-dose inhalers, transdermal patches, and drug-eluting implants. If the CDMO only manufactures the drug component (bulk drug product) and a separate manufacturer assembles the device, the drug CDMO may not need ISO 13485.
How does ISO 13485 differ from ISO 9001?+
ISO 13485 is tailored for medical devices with specific requirements for: design and development controls, risk management (ISO 14971 integration), traceability, sterilization validation, and regulatory reporting. Unlike ISO 9001, which encourages continuous improvement as a concept, ISO 13485 focuses on maintaining the effectiveness of the quality system specifically for safe medical device production. It does not include the improvement-focused requirements of ISO 9001.
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