Regulatory Consulting

What sets Empirical apart?

  • Expertise in U.S. and International regulatory clearance and approval 
  • Empirical is 20% to 30% FASTER than the industry average in obtaining FDA clearance
  • 100% success in FDA submission clearance that redefines the “industry standard”
  • Deep long-standing relationships with regulatory agencies
  • All staff are RAPS trained and/or certified (RAC)
  • 40 + years of combined regulatory & consulting experience

EMPIRICAL IS YOUR EXPERT PARTNER TO SUCCESSFULLY GAIN AND MAINTAIN
REGULATORY CLEARANCE AND APPROVAL

Empirical has deep, long-standing relationships with regulatory agencies to provide a direct, shorter path to market. Through collaboration and trusted consultation, we guide you through the evolving and ever changing path of achieving regulatory clearance, the FIRST time. We have proven successes throughout the world at helping our clients navigate through the process to reach their goals effectively and efficiently. By starting at the concept phase of product development, we can identify the differentiators and efficacy of your product to focus on solutions specific to your device. With Empirical, you will receive comprehensive, TRUSTED regulatory consulting that you be confident in.

  • 510(k) Submission for devices to be sold in the U.S., including combined tissue/device products
  • Technical files for devices to be sold internationally (CE Marking)
  • Clinical literature review
  • Steam sterilization and cleaning verification
  • Shipping/distribution validation
  • Mechanical testing protocol generation with acceptance criteria based on published literature
  • Regulatory and mechanical justification memos
  • Compliance support
  • 21 CFR 820 and ISO 13485 compliant quality systems
  • Education programs and courses
  • Literature research, patent searches, report & white paper generation
  • Audit services
AUDIT SERVICES
Internal Audits  |  FDA Gap Analysis  |  ISO 9001 Gap Analysis  |  ISO 13485 Gap Analysis  |  Supplier/Vendor Audits

EMPIRICAL REGULATORY CONSULTING REDEFINES "INDUSTRY STANDARD"

Phone:

+1 719.457.1144

Address:

4628 Northpark Drive Colorado Springs, CO 80918

E-mail:

info@empiricaltech.com