TD diagnosis before submission

Reconcile your business with your regulatory challenges

A step ahead in your monitoring

QMS AUDIT

An objective and shared perspecive on your organization

 

 

 

Firefighter missions

Count on Nexialist to stand by your side, holding the fire hose, and extinguishing regulatory fires

Clinical evaluation

The synthesis of your clinical data: a cornerstone in demonstrating the performance and safety of your medical device

Electrical safety

No more fear of getting shocked, nexialist secures your regulatory meter

Technical documentation

A clear and complete dossier to obtain your ultimate goal: the CE mark

Design & Development

Obtain a relevant methodology to master a simplified and operational design

 

Process validation

Your turnkey validation solution, optimized and compliant

 

Post-Market Surveillance

Demonstrate the safety and performance of your medical device throughout its lifecycle

Due diligence

Make informed decisions by assessing the regulatory health of your business