Repetitive CAPAs and investigations are more then ever the target of the regulator, we'll support your effort to get where you want your systems to be.
FDA and HC Remediation Plans
Repetitive CAPAs and investigations are now more then ever the target of the regulators, we'll support your efforts to get where you want your systems to be. FDA 21-CFR-829 audits are evolving and it is the same with the ISO and Health Canada Regulations, navigating through the changes and evolution, while delivering the Day to Day Operation can be a challenge for the Medical Device Industry. with a trusted reliable partners you'll always be in a strong position.
Medical Device Auditing
Preparation is key, let's effectively expedite this process while covering in depth the applicable systems and processes.
Medical device regulatory affairs
Our team can bring more capacity for your Reg Affairs department when needed.
Medical post-market surveillance (PMS)
Keeping track of the product performance post market is a key system, which is an areas of focus of the regulators
Process Improvements
Doing More With Less, always a pleasure.
Quality By Design
The good start is the right start.
Software Testing
Before Going-Live we make sure it works as expected.
Sterile Medical Device QMS
Your KPi(s) are critical standards for us.
System Engineering
From User Requirement, to Design, To Test, To Validation, to Go-Live we're with you all the way.
Validation and Qualification
Specific Validation projects, short term or mid term, we'll suggest you the most effective GMP approach applicable nothing more.
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