EMPIRICAL

Medical Device Mechanical Testing

With over 20 years of trusted experience, Empirical is your expert partner for mechanical testing, providing comprehensive & proven solutions. We specialize in the testing of medical devices and components for the aerospace and defense industry.

ISO/IEC 17025:2017 Accredited

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EMPIRICAL

Regulatory Consulting Services & Validation

Empirical has a trusted reputation and is the expert in U.S. and international regulatory clearance and approval.
We have a long-standing relationship with regulatory agencies, provide audit services and quality systems development and improvement. Together, we can guide your project on a faster road to success.
RAPS trained and/or certified (RAC)

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MEDICAL DIVISION

Empirical is your trusted partner to successfully gain and maintain regulatory clearance and approval. We offer a complete package of medical device mechanical testing services with the goal of getting FDA clearance or approval the first time.

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ISO/IEC 17025 : 2017 Accredited

Empirical has the widest scope of accreditations for any independent testing lab in the U.S.

MECHANICAL TESTING LAB

MECHANICAL TESTING SERVICES

We are your trusted partner for accurate mechanical testing for over 20 years. Empirical provides fast, comprehensive test reports to guide you to successful project completion.

REGULATORY & CONSULTING

Empirical Technologies Corp. is the leader in successful FDA 510(k) submissions with over 200 submitted. Our submissions clear 20% – 30% faster than industry average.

QUALITY STANDARDS

Quality is our highest priority under our ISO 17025 : 2017 accreditation from A2LA. We set the standard for quality assurance. Empirical also holds certifications for ISO 9001.

MEDICAL DEVICE TESTING DIVISION

Empirical’s scope of mechanical testing is one of the largest in the industry under our ISO 17025 accreditation. We are the leader in the testing and submission of orthopedic devices.

EUROPEAN MEDICAL DEVICE REGULATION

Empirical Technologies Corp. is ready to support and guide clients through the upcoming EU MDR implementation. Our expertise in regulatory on a global scale is unmatched.

THE EMPIRICAL DIFFERENCE

We partner with our clients across a wide range of testing solutions to help them get the right solution for their needs. We want to provide guidance, perspective, and our experience to enable them to make the best products to improve people's lives.

TRUSTED REPUTATION

With over 20 years in the mechanical testing industry, our team of experts work with top global companies who expect exceptional service and results.

COMPREHENSIVE, PROVEN SOLUTION

Our combined services & expertise create efficiency & cohesive project knowledge from start to finish. We provide accurate quoting and guidance to complete the necessary services for your project.

PARTNERSHIP

We are an extension of your team providing expert guidance & timely execution. Your success is our success.

GLOBAL SERVICES

Clients around the world turn to Empirical for guidance and support in prototyping, testing, and consulting.

Quality & Integrity

Empirical quality, service, and integrity provides our clients with results they expect and rely on.

THE RIGHT SOLUTION

Time = $$$. As your partner, we are committed to providing the RIGHT solution EVERY step of the way.

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

When your product or device is ready for testing, it is essential that you work with a medical device testing company that will help you realize timely and effectual market success.

WHY CHOOSE EMPIRICAL?

The Empirical Method for Success is the proven process that our global clients rely on for their projects. From accurate quoting to our expert gap analysis, our combined services will help your project to a faster path of completion. Empirical has all of the pieces for success.

Time = $$$

CASE STUDIES

We are proud to show you our projects that were made with all our skills and professionalism.

WHAT PEOPLE THINK ABOUT US

Frankie L. Morris at Bone Solutions, Inc.

“Empirical does a great job that is why [I] keep coming back. Why would I go anywhere else?”

Adam Rogers at Spine Simplicity

“Very smooth process….test blocks and testing was done quickly, and exceeded his expectations of time frame. The fact that the test engineer offered to have a recap conference call to review the testing, this was very useful, was very appreciative of that opportunity to have that conversation after the testing was complete. It helped in…

Andrew Rogers at SpineEX

“The Empirical Team has once again proven instrumental to our business and RA/QA efforts by assisting us with yet another successful 510(k) submission and clearance!”

Sr. Engineer at Integrity Implants Inc.

“Empirical has been a knowledgeable and responsive extension of our Regulatory Affairs team. We are looking forward to our future collaborations.”