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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.