Medical Technology

Our Medical Technology Services

Ensuring compliance and documentation of international medical device quality management systems.

Assistance in obtaining CE marking for medical devices intended for the European Union market.

Compliance with requirements of the U.S. Food and Drug Administration (FDA), particularly 21 CFR Part 820 (Quality System Regulation).

Identification, evaluation, and management of potential risks associated with medical devices.

Assistance in preparing Clinical Evaluation Reports (CERs) to demonstrate the safety and effectiveness of medical devices.

Improving manufacturing process efficiency and applying waste reduction techniques.

Facilitating medical device audits with a single audit program accepted in multiple countries.

Understanding and compliance with regulatory requirements for digital health applications.

Qualifying, auditing, and continuously monitoring supplier performance.

Medical devices – Quality management systems – Requirements for regulatory purposes.

Medical devices – Application of risk management.

Medical device software – Software life cycle processes.

FDA regulation of quality management systems in the United States.

Universal audit program for medical device organizations.

MANAGEMENT – CONSULTING – TECHNOLOGY – RELATIONS