Services for

REGULATORY & CONSULTING

AUDIT SERVICES

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

  • INTERNAL AUDITS

  • FDA GAP ANALYSIS

  • ISO 13485 GAP ANALYSIS

  • SUPPLIER/VENDOR AUDITS

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

Through collaboration, we guide you through the evolving and ever-changing path of achieving regulatory clearance. We have proven successes throughout as an FDA quality and regulatory consultant at helping our clients navigate through the process to reach their goals effectively and efficiently. With Empirical, you will receive comprehensive, TRUSTED regulatory consulting that you can be confident in.

Contact us to learn more

Regulatory Consulting 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)
  • FDA quality and regulatory consulting
  • 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 regulatory consulting services

TIME TO OBTAIN FDA CLEARANCE

Our Average Review Days
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Industry Average Review Days
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Number of Successful 510(k) submission
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YOUR REGULATORY EXPERT

Meredith May, RAC, CQA is a biomedical engineer, who 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 clients from a FDA and regulatory consultant.

EMPIRICAL'S REGULATORY AFFAIRS CONSULTING SERVICES REDEFINE "INDUSTRY STANDARD"

Empirical Europe 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. Contact our FDA Quality and Regulatory Consultants today!