Quality management ISO 13485

A successful ISO 13485 certification provides far-reaching business opportunities for companies involved in the medical device industry, either as service providers or manufacturers of its own medical products.

OPTANA supports enterprises during the initial setup or maintenance of their process landscape targeting a successful (re-) certification of the internationally established quality standards ISO 13485.



Quality system regulation for USA (CFR 820)

Medical device approvals in the US require compliance with the quality system regulations (QSR) defined by the Food and Drug Administration (FDA) that are in many aspects more demanding than ISO 13485 quality management requirements.

Due to many years of fruitful cooperation with US medical device manufacturers, OPTANA is familiar with the implementation of the QSR / CFR 820 standard including the specialties related to it.



Risk management (ISO 14971)

To proof safety in a transparent and comprehensible manner is a highly complex, but indispensable activity that starts already at the very beginning of the development. Due to the interdisciplinary nature of risk management, reaching from clinical aspects down to deeply technical questioning, highest attention, experience and excellence is required.

OPTANA supports companies in their risk management activities and during the generation and maintenance of the top-level DHA (Device Hazard Analysis) (DHA) as well as for FMEAs (Failure Mode and Effect Analysis) related to the designs and processes.



Vigilance and CAPA

CAPA (Corrective And Preventive Actions) processes need to become immediately active after potential life-threatening device defects or non-compliances have been detected. Furthermore and according to the applicable vigilance processes manufacturer must inform national competent authorities (NCAs) regarding the decided field safety corrective actions (FSCA).

OPTANA supports companies in the definition, implementation or auditing of respective vigilance and CAPA processes.



Compliance Master

Our ready to go medical process landscape (Compliance master) allows for a compliant start within the medical technology business and a rapid ISO 13485 company certification.

Once implemented, the integrated working methods will result in well organized, transparent workflows and guidance for all employees

The process landscape includes all processes and templates necessary to document all activities required by the National Competent Authorities routinely auditing and supervising medical device manufacturers.