Pre Market Services

 

 Premarket Services

Verification and validation of medical devices.

Testing is a critical step in the transformation process of innovative design in a reliable and marketable product. Thus it has been created solutions for technology assessment. Tests to help you demonstrate your device is compliant with the regulations anywhere in the world. 

 

Advice and support in certification of medical devices

This brand is in charge of researching and advising on quality management processes that indicate compliance with required international standards such as ISO 13485, ensuring that its products are manufactured under a strong quality control and risk management policy.

 

Advice on certification processes for manufacturers and laboratories.

Created to study and advice on developing a quality management system for new test laboratories and medical device developers that fit the best to ensure that all medical device processes are taken into account.

 

Design of evaluation protocols for medical devices

The evaluation process is carried out not only to verify if the product meets minimum requirements but to propose and establish footholds for the manufacturer be prepared to build a quality device.