Consulting

U.S. & International Regulatory and Quality Expertise for Your Team

When your medical device is completed, it is time to realize timely and effectual market success.

We are your medical device consulting partner to gain and maintain U.S. and international regulatory clearance for your medical device design. Empirical Consulting (EC) 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 various sectors of 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.

With more than 50 years of combined experience in the medical device industry, we know how to successfully bring your medical device to market.

Medical device consulting performance charts

Watch the Empirical Consulting Overview Video

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Your Partner in developing medical devices for the world market.

Partner with the family of Empirical companies (Empirical Consulting, Empirical Testing Corp., and Empirical Machine) to bring your innovative, safe, and effective medical devices to market.We are the international company that will deliver exceptional service, value, and support to help you gain and maintain regulatory clearance or approval.

 

Innovation • Integrity • Industry Experience

Empirical Consulting redefines “Industry Standard”

Through collaboration and consultation, we guide you through the evolving and ever changing path of achieving regulatory approval, the first time. Our vastly trained and experienced medical device consultants have proven successes throughout the world at helping our clients navigate through the process to reach their goals effectively and efficiently.

  • All regulatory support, including review, deficiency response, and compilation
  • Quality system development and improvement
  • Audit services by ASQ Certified Quality Auditor (CQA)
  • All staff are RAPS trained and/or certified (RAC)

Sector Expertise

Manufacturing | Validations | Quality | Regulatory | Development | Biologics | Auditing

  • Comprehensive Consulting Services
  • Deep, long-standing relationships with regulatory agencies
  • 510(k) submissions 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 reviews
  • Steam sterilization and cleaning validation
  • Shipping/distribution validation
  • Mechanical test 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 and white paper generation
  • Audit services – internal, FDA gap analysis, ISO 9001/ISO 13485 Gap Analysis, as well as supplier/vendor audits

Sample of medical device parts our consultants use for verifications

FDA clearance to market:

Industry average: 85%
Empirical Consulting average: 100%

Time to obtain FDA clearance:

Industry average: 135-days
Empirical Consulting average: 105-days

Empirical Tech

Empirical Tech

Consulting, Testing, Manufacturing and Validation Services for Medical Sevice Companies

Empirical Testing

Empirical Testing Corp.

The Experts in U.S. & International Comprehensive Mechanical Testing

Empirical Machine

Empirical Machine

Your Partner in Medical Device Prototypes and Small Batch Manufacturing