REGULATORY & CONSULTING SERVICES

REGULATORY & CONSULTING SERVICES

SERVICE OVERVIEW

clock reading Time is Money

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 Technologies Corp. IS YOUR EXPERT PARTNER TO SUCCESSFULLY GAIN AND MAINTAIN
REGULATORY CLEARANCE AND APPROVAL

Empirical Technologies Corp. 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.

Regulatory Services

  • 510(k) Submission for devices to be sold in the U.S., including combined tissue/device products
  • All regulatory support, including review, deficiency response, & compilation
  • Quality system development and improvement
  • All staff are RAPS trained and/or certified (RAC)
  • 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

Time to Obtain FDA Clearance

   Our Average Review Days:

   131

   Industry Average Review Days:

   177

Number of Successful 510(k) submissions:

Over 200

AUDIT SERVICES
Audits services provided by an ASQ Certified Quality Auditor (CQA)

Internal Audits  |  FDA Gap Analysis  |  ISO 9001 Gap Analysis  |  ISO 13485 Gap Analysis

Supplier/Vendor Audits

Your Regulatory Expert

Meredith May, RAC, CQA is a biomedical engineer, brings decades of orthopedic implant industry experience in manufacturing, design, regulatory and quality to your project team. She has been successful at bringing orthopedic products to market on shoestring budgets with condensed timelines, so she understands the needs of orthopedic implant companies.

EMPIRICAL REGULATORY CONSULTING REDEFINES "INDUSTRY STANDARD"

Empirical Technologies Corp. has extensive sector specific, speed-to-market expertise to help you navigate through the regulatory process as quickly and seamlessly as possible. Our experts from the medical device, quality, regulatory, and biologics industries have the connections and skills to help you achieve your goals in a cost effective and efficient fashion.

Phone:

+1 719.457.1144

Address:

4628 Northpark Drive Colorado Springs, CO 80918

E-mail:

info@empiricaltech.com