Medical Device Services
Since many years we are working with regulated industries and we can help you reply to your compliance needs.
This could be obtained through an analysis, a study or to an assessment done on the devices, to understand together if there is the right maturity level to be aligned with the requirement of the market your company would like to support.
Our consulting services could contribute to your success in different phases including:
- Analyse the products and the data they are processing
- Make a market analysis to understand any possible conflict with local and industry regulations including GDPR, FDA, HIPAA, ISO 13485, ISO 14971, ISO 29151, ISO 80001 or ISO 81001
- Assess your devices and run control checks to define a gap analysis against regulations
- Report findings, understanding an action plan and a roadmap
- Design controls
- Define how data should be acquired, processed and disposed
- Make your design to become real
- Project management