RMS Regulatory & Marketing Services
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We'reReady

Our team of consultants is ready to assist your organization in bringing your medical device to the U.S., European and Canadian markets. Whether a small start up firm needing a complete quality management system, or an established market leader with a new medical device concept, we offer the services to fulfill each of your regulatory or quality related needs.

GlobalServices

We serve clients from the U.S., Canada, Mexico, China, Japan and Taiwan and countries in the European Union and South America.

With nearly 300 clients worldwide we have experience with a wide range of different medical devices and cosmetics; including but not limited to orthopedic, radiological, ophthalmic, general and plastic surgery, cardiovascular, anesthesia, respiratory, gastroenterology/urology as well as dental and cosmetic products.

AJW TechResources

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Welcome

AJW Technology Consultants, Inc. and its affiliates RMS, Inc. and RMS UK Ltd. provide a wide range of quality and regulatory services for the medical device and related industries. A snapshot of our services is available below. Click on the heading to learn more about the service.

ServicesOverview

Quality Management
  • Quality system development;
    • FDA cGMP,
    • ISO 13485: 2003,
    • ISO 9001:2000,
    • ISO 14971:2007,
    • CMDR,
    • MDD
  • Internal and supplier audits;
  • Quality system training
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Regulatory Consultation
  • General product and industry research,
  • Acquisitions due diligence,
  • Manufacturing support and site selection,
  • Training seminars,
  • On-site regulatory support
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Adverse Event Management
  • United States;
    • Complaint Management,
    • Medical Device Reports,
    • Corrections, Removals, Recalls
  • Europe;
    • Complaint Management,
    • Adverse event and vigilance reports
  • Canada;
    • Complaint Management,
    • Problem reporting and recalls
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Product 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 file,
    • Authorized representative,
    • Risk management support,
    • Clinical evaluation
  • Canada;
    • Medical device license
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Labeling Review and Design
  • Regulatory requirement labeling reviews
    • FDA
    • MDD
    • CMDR
    • EN 980:2008
    • EN 1041:2008
  • Labeling design and development
    • Product labels
    • Instructions for use
    • Marketing materials
    • Newsletters
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