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.
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.