OaCP has obtained ISO 13485:2016 certification, a strategic milestone confirming that its Quality Management System complies with the requirements of the medical device sector.

The company, incubated and affiliated with Bio4Dreams, develops reagents and solutions for in vitro diagnostics, with a particular focus on oncology, cytogenetics, and molecular diagnostics.

The certification represents a further step in the company’s growth journey and strengthens its management of quality and regulatory requirements.

ISO 13485:2016 certification

ISO 13485:2016 is the international reference standard for Quality Management Systems in the medical sector. It defines specific criteria that help organizations manage their activities in a structured manner and maintain processes aligned with customer needs and industry standards.

For OaCP, the certification covers the design, development, and distribution of in vitro diagnostic medical devices. Its scope includes FISH reagents and probes, molecular diagnostic reagents, PCR-based diagnostic kits, nucleic acid detection kits, rapid antigen tests, serological diagnostic devices, and products related to oncology, cytogenetic, and molecular diagnostics.

For hospitals, laboratories, research centers, and diagnostic-sector partners working with OaCP, this means relying on products developed and distributed through defined, controlled, and traceable processes.

A foundation for future development

ISO 13485 represents an important milestone in OaCP’s journey toward compliance with the European In Vitro Diagnostic Medical Devices Regulation (IVDR), which introduces a more rigorous regulatory framework for the quality, safety, and performance of in vitro diagnostic medical devices.

Building on this foundation, the company can continue its regulatory pathway with an increasingly robust organizational structure aligned with industry requirements.

The certification also strengthens OaCP’s operating model and supports its scalability, contributing to business development activities, the consolidation of partnerships, and growth in the Italian and European markets.

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The cover image was generated using artificial intelligence for illustrative purposes and does not depict OaCP’s actual facilities, personnel, or activities.