5AI creates your successful pathway to regulatory approval and commercialization with the following key activities.
– Applying subject matter expertise to understanding your needs.
– Taking your product to a new regulatory environment such as USA FDA.
– Adapt and tune to the project needs with the applicable expertise.
– Full service from idea through product commercialization.
– Full post market support, keeping your product aligned with regulatory changes: MDD to MDR, IVDD to IVDR taking your product to a new regulatory environment such as FDA.
Hands-on Get Things Done
The 5AI team do not just tell you what is required.
– We are measured by, and accountable for our actions.
– We are not afraid of the tedious meticulous work required for getting documents regulatory submission-ready.
– We strive to enable your organization to generate regulatory submission-ready documents, first time right.
Quality Assurance and Regulatory Affairs
Quality Assurance and Regulatory Affairs are essential to Medical Device and In Vitro Diagnostic Medical Devices around the world. 5AI helps you use Quality Assurance and Regulatory Affairs to empower your business by:
– Optimizing Time To Market.
– Reducing gaps in Product Risk Management.
– Optimising Post Market Surveillance and Follow-up.
– Streamlining Quality Management to align with real business needs.
– Training and supporting teams within companies to get the most out Quality Assurance and Regulatory Affairs
Get in touch now for a free Initial Regulatory assessment of your business