Product| Process - QMS Audit, Elaboration, Development
GENOTRIX can help you and develop your QMS System from the initial steps to the final certification. If you have already a QMS system implemented we can also setup a local audit for several purposes.
In the end, and no matter the approach, you’ll get a report for improvement or other relevant questions and issues we think you can adjust and optimize to get a more solid system.
Regulatory Expertise (CE Marking)
Ask for more information and procedures to apply for the CE Marking and start your entrance to the market.
Device Development Planning (Design & Engineering )
Our knowledge and experience will accelerate your medical device design and development and help you to get a fast manufacturing process and control of your medical device.
Contact us for questions and strategies to get your medical device ready to enter the market. We will guide you at each single step you need to fulfil to be compliant.