Services Overview

“AJW Technology Consultants and its affiliates provides a broad range of services, designed assist your organization in bringing your medical device to the U.S., European and global marketplaces. Below is a list of common services provided by our team. Please click on the links below or use the services drop down list in the banner above for more detailed information.”

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

Reimbursement Strategy

Assessment of product categorization, existing codes, and new code applications