Product definition and refinement services, software and hardware development and engineering, quality system compliant development, validation and testing services.
Global device registrations, post market surveillance, access to former US FDA staff, in-county representation.
ISO 13485 and ISO 9001 quality systems development, MDSAP and MDR gap assessments, FDA inspection preparation, internal and supplier audits, contract manufacturer due diligence and selection.
Market research, branding, advocacy, new product launch, distribution and sales support
Corporate Strategic Planning
Strategic planning services to assist with corporate structure, financing, investors, messaging and overall branding
Adverse Event and Recall Management Support
Assessment of product categorization, existing codes, and new code applications