Services Overview

Core Services for the Medical Industry

“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 Development

Product definition and refinement services, software and hardware development and engineering, quality system compliant development, validation and testing services.


Global Regulatory Strategy and Compliance

Global device registrations, post market surveillance, access to former US FDA staff, in-county representation.


Quality Management Solutions

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.

Labeling Review & Design

  • Regulatory requirement labeling reviews
    • FDA
    • MDD
    • MDR
    • MDSAP
    • UK
    • CMDR
    • EN 980
    • EN 1041
    • ISO 15223
  • Labeling design and development
    • Product labels
    • Instructions for use
    • Marketing materials
    • Newsletters

 

Sales and Distribution Management

Market research, branding, advocacy, new product launch, distribution and sales support

  • Sales Strategy
  • Marketing Strategy
  • Distribution Strategy
  • Market Overview
  • Initial Market Interview
  • Business Plan
  • Direct Sales
  • Overview Management for Distribution
  • Advocacy Management for Distribution
  • Contracting of Key Opinion Leaders
  • Test Market Sales

 

Corporate Strategic Planning

Strategic planning services to assist with corporate structure, financing, investors, messaging and overall branding

  • Corporate finance strategy
  • Business Modeling
  • Investor pitch
  • Website design and messaging
  • Budget creation

Regulatory Submissions

  • United States;
    • 510(k) Premarket Notification,
    • IDE (Investigational Device Exemption),
    • PMA (Premarket approval),
    • Establishment registration,
    • Device listing,
    • Official Correspondent,
    • US Agent
  • Europe;
    • CE Mark technical documentation
    • Authorized representative
    • Risk management support
    • Clinical evaluation
    • Post market surveillance
  • United Kingdom;
    • UK Responsible Person
    • MHRA manufacturer, importer, distributor registrations
    • MHRA medical device registration
  • Canada;
    • Medical device license
    • Regulatory correspondent
  • Australia
    • Australia Sponsor
    • ARTG Listing Application
  • New Zealand
    • New Zealand Sponsor
    • WAND Database Submission
  • India
    • India Authorized Agent
    • CDSCO product registration

 

Adverse Event and Recall Management Support

  • United States;
    • Complaint Management,
    • Medical Device Reports,
    • Corrections, Removals, Recalls
  • European Union;
    • Complaint Management
    • Vigilance reports
    • Field Safety and Corrective Action
    • Notified Body and Competent Authority communication
  • United Kingdom;
    • Complaint Management
    • Adverse event and vigilance reports
    • Field Safety and Corrective Action
    • Notified Body MHRA communication
  • Canada;
    • Complaint Management,
    • Problem reporting and recalls

 

Reimbursement Strategy

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

  • Reimbursement code identification
  • Reimbursement code consensus planning with agencies
  • Gap assessments
  • Strategy building