Industry Leaders

Our team of experienced consultants will help deliver on milestones across all stages of development and commercialization while providing guidance to the latest regulations.

 

Areas of focus that we offer to industry leaders:

- Global regulatory submissions with support during review:

FDA pathways, EU CE Mark (MDD/AIMDD/IVDD and MDR/IVDR considerations), LATAM, Canada, Australia, UK, ROW

- Continued compliance activities for FDA 21 CFR 820, EU MDR, and ISO 13485

- Specialized functional resources and support for completion of project deliverables

- Project planning and management

- Preparation and review of technical documentation

- Remediation plan assistance and completion of audit commitments