Compare CDMOs with ISO 13485 certification for medical device and combination product manufacturing. Filter by device type and manufacturing capabilities.
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).
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