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Brookhaven Medical, Inc.
Corporate Headquarters
info@brookhavenmedical.com

Monarch Tower
3424 Peachtree Road N.E., Suite 1150
Atlanta, GA 30326

Tel: 404-205-8282
Brookhaven Technologies
info@brookhavenmedical.com

1605 Enterprise Street
Athens, TX 75751

Tel: 903-677-9166
Brookhaven Vascular
info@brookhavenmedical.com

200C Patewood Drive, Suite 4125
Greenville, SC 29615
Tel: 864-242-4700
Our Brookhaven Technologies Group has been developing and manufacturing innovative medical devices for major medical device companies since 1993.
CAPABILITIES
FutureMatrix Interventional, Inc. doing business as Brookhaven Technologies, located in Athens, Texas is home to both our technology group and our manufacturing teams. We have everything required to take a novel idea from concept through to high volume manufacturing of finished medical devices under one roof.

DEVICE DEVELOPMENT
Our design & development teams will partner with you through all stages of device development, from initial disclosure and protection of Intellectual Property to design for manufacture activities. With numerous patents and proprietary processes under their belt, our team is comprised of experts in research, product development, high volume manufacturing, and regulatory affairs professionals that bring years of experience to support our customers.

QUALITY SYSTEMS
Our quality management system is designed to navigate any regulatory path requirements and support the development of any new device technology. Our Athens campus is an FDA registered facility utilizing quality systems that are compliant with FDA QSR regulations. We are an ISO 13485:2003 certified and Brazil ANVISA certified facility. We comply with USFDA CFR 21 820 and Japan MHLW Ministerial Ordinance 169.

MANUFACTURING CAPABILITIES
We have both pilot manufacturing, clean room manufacturing and full scale high volume manufacturing capabilities at our Athens campus.  Our manufacturing technologies include:

  • Precision Extrusion
  • Injection Molding
  • Laser Technology
  • Medical Balloon Blow Molding
  • Centerless Grinding
  • Post Extrusion Tube Processing

  • Surface Coatings
  • Laser and Pad Transfer Printing
  • Adhesive and Thermal Bonding
  • Finished Device Assembly
  • Device and Component Inspection
  • Bulk and Sterile Barrier Packaging

REGULATORY STRATEGIES
We can be your partner in developing a comprehensive regulatory strategy for your new medical device. Our regulatory team will be an active participant on the project team from the initiation of the project providing guidance and regulatory opinion. Once the design has matured to the appropriate point, they will craft a regulatory submission plan and the requisite documentation to support the various submissions (Pre-Submissions, 510(k)s, 513(g), Technical File, etc) and guide and/or manage the interaction with the regulatory agencies.