Our experienced consultants can prepare your products for entry into additional regions. In doing so, your organization will benefit from enhanced audit readiness, quality distributor relations, and a roadmap to subsequent registrations.

 

Areas of focus that we offer small and mid-sized companies:

- Flexible support to meet fluctuating resource needs

- Regulatory strategy based on device category and desired markets

- Identification of applicable region-specific requirements for your product

- Project planning and delivery on established timeline and budget

- Quality Management System (QMS) improvements to enhance overall development efficiency

- Preparation and review of technical documentation

- Readiness for region-specific certification, with audit support

- Evaluation of distributor/vendor and regional representatives

- Global regulatory submissions with support during review

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