Credence MedSystems has secured ISO 13485:2016 certification for its quality management system, a milestone the drug-delivery technology company says strengthens its position as a potential development and supply partner for pharmaceutical and biotechnology companies. BSI issued the certification, which covers Credence’s quality management system for the design and manufacture of medical-device-related products.

For drug developers working on combination products, the qualification of a delivery device supplier can be an important part of advancing a program toward commercialization. ISO 13485 is an internationally recognized quality-management standard focused specifically on medical devices and related manufacturing activities. Credence said the certification is intended to demonstrate that its quality and manufacturing infrastructure can support pharmaceutical and biotech programs beyond the early stages of device development.

“ISO 13485 Certification is an important milestone in Credence’s evolution,” says Lisa Caparra, Director of Quality Assurance at Credence MedSystems. “Pharmaceutical companies need delivery technologies supported by the quality systems, manufacturing processes and supply infrastructure necessary to move programs toward commercialization.”

The certification comes as Credence develops a portfolio of drug delivery platforms designed around different pharmaceutical formulation and administration requirements. The Credence Companion platform provides integrated passive safety features for prefilled syringes across volumes ranging from 1 mL to 5 mL. The company also offers a dual-chamber syringe system intended for drug products that require separate storage of components before administration. The system can be configured for reconstitution or sequential injection of two liquids. For ophthalmic applications, Credence’s Micro-Dose syringe is designed to support precise intravitreal drug delivery.

The company positions these technologies as solutions to drug-delivery challenges encountered by pharmaceutical and biotechnology developers, rather than as standalone device products. “Our customers are not simply looking for a device—they are looking for a solution to a drug delivery challenge and a path to getting their therapy to the patients that need them,” says Sian Eden, Commercial Director at Credence MedSystems.

Credence said the new certification represents another step toward becoming a “ready-to-supply” partner for pharma and biopharma companies. The designation is particularly relevant as drug developers increasingly evaluate delivery systems alongside the broader manufacturing, quality and commercialization requirements associated with combination products.

The ISO 13485 certification does not itself indicate regulatory approval of any particular drug or combination product. Rather, it provides a framework for the company’s quality-management processes as it works with customers developing drug-delivery products.

Credence’s portfolio spans safety syringes, dual-chamber delivery systems and micro-dose technology, giving the company platforms aimed at different stages and routes of drug administration. The company said its quality system milestone is intended to support the transition of those technologies from development programs toward commercial supply.

To learn more, visit www.credencemed.com.