Med Tech Quality and Regulatory Affairs Consultants for Global Market access.

 Medical Devices, In Vitro Diagnostics, Healthcare Software and Pharmaceuticals. 

Quality and Risk Management Systems

Quality Management Systems  - ISO 13485
Risk Management Systems - ISO 14971

We implement Simpler, Safer and  Compliant procedures.

Regulatory Affairs


We give you access to  Europe, the United States, Asia and other International markets. 

Process Reengineering

SOP procedures lean optimisation optimization

Quality, Compliance  and  more Productivity can be achieved at the same time.