Medical Devices Consulting.

Challenge.

A medical device company needed to ensure that its products complied with the new MDR regulations in order to remain approved in global markets. The challenge was to develop a comprehensive compliance program that would meet all regulatory requirements worldwide.

Measures.

• Development of a holistic MDR compliance program that integrates all global regulatory requirements.
• Creating and updating technical documentation to ensure that all products comply with the new MDR requirements.
• Conducting mock audits in preparation for official tests and audits by notified bodies.

Results.

• Timely and successful implementation of the MDR compliance program.
• Timely approval of products in several international markets.
• Improved preparation for external audits through a complete review of technical documentation.

Success.

The company was able to successfully place its products on the global market and fulfill all regulatory requirements.

Challenge.

Measures.

• Support in the creation and updating of Clinical Evaluation Reports (CERs) and Performance Evaluations for existing products.
• Introduction of standardized processes to ensure GCP conformity (Good Clinical Practice) and compliance with all relevant ISO standards (14155/20916).
• Optimize collaboration with clinical research organizations (CROs) to efficiently collect and manage clinical data.

Results.

• Timely submission of all required clinical documentation to the competent authorities.
• Ensuring MDR compliance of the clinical evaluation processes.
• Improved efficiency in the creation and management of clinical data through optimized processes.

Success.

Challenge.

A medical technology company was struggling to ensure the quality of its production processes and implement efficient CAPA (Corrective and Preventive Action) management. The company also had to prepare for upcoming audits.

Measures.

• Implementation of an optimized CAPA management system that was specifically tailored to the company's requirements.
• Implementation of training courses to improve process quality and support in preparing for external audits.
• Introduction of a system for continuous monitoring and improvement of production processes in order to identify and rectify deviations at an early stage.

Results.

• Significant reduction in process deviations and improvement in product quality.
• Successful completion of several external audits.
• Optimized processes for the early detection and elimination of production problems...

Success.

By optimizing internal processes and introducing effective CAPA management, the company was able to bring its products to market more efficiently and safely, while at the same time meeting all regulatory requirements.