AI Empowered Risk Management Tool for Medical Device Compliance

We have developed the next level of compliance software for Medical Device tackling one of the most complex process and the one around entire product development should be build, which is indeed Risk Management.

Our company is ISO 13485:2021 certifed.

Our team comes from long experience in Medical Device and Pharma companies. 

We have been supporting companies ranging from start-ups to bluechips in making their products compliant to ISO 14971, ISO 13485, MDR and FDA guidances about risk management.

Facing a number of challenges that goes from understanding well the type of device and related failure modes and hazards, necessity to find best balance with existing documentation in case of remediation projects, importance to take lean and scalable approaches for start-up and innovative devices

So we have seen and executed Risk Management in all kind of scenario and condition

Need of a tool was always considered but until recent AI developments it was probably not worth working on an automated solution with limited real benefit for the users.

The innovative tool we are developing instead aims to automate the entire spectrum of risk management documentation, including

• Risk Management Plan,
• FMEAs,
• Hazard Analyses,
• Risk Benefit Evaluations
• Risk Management reports.

Specific AI agents have been trained and assigned to the different task and orchestrated by an overall RM Lead Agent

Our system allows safe and controlled storage of sensible information of client company into our cloud segregated from third parties.

The tool we have developed is based on our team more then 250 years of experience of our team in dealing with:

• Combination products
• Dermal Fillers
• Implantable devices
• Active Medical Devices
• Software as Medical Device
• Substance Based Devices

Each type of device has his own kind of hazards and specifc pecualirities and standards to be considered, we have a dedicated Risk Management solutions for each type of device!

Write to info@tsquality.ch for more info

We can support also with:

• Clinical Evaluations
• Biological Evalautions
• Human Factor Engineering
• MDR Submission
• FDA submission
• Audit Planning ISO and MDSAP
• eIFU platform
• Worldwide registrations