Regulatory Affairs

Regulations follow-up

STATICE can follow-up and/or help you to design and develop any technical documentation for your product under the 93/42CEE standards which includes:

• Choosing the required organism
• Classification of your medical device
• Claimed use
• Risk management file under the EN ISO14971:2016 standards
• Responding to essential needs
• Identifying applicable standards for the products
• Validation strategy for the products or processes.

 
STATICE can also help you to design your own Quality Control procedures under EN ISO13485:2016 standards with an initial audit to approve the certification for a final audit. 

Training

STATICE is authorised to provide training courses for their goods and is registered under n°43 25 02741 25 in France, and can offer training courses in the following fields:

• Marketing a medical device
• Designing technical documentation
• Achieving results for risk management
• Understanding and setting-up procedures for validating processes
• Understanding the requirements for working in a sealed environment
• Conducting internal audits
• Understanding the ISO13485 standards.