Empirical Technologies

medical devices

About

Empirical Technologies is a woman-owned company based in the U.S. that specializes in medical device testing, research and development, engineering services, and regulatory consulting. Founded in 1998, the company has over 20 years of experience and is recognized as a global leader in its field. It holds ISO/IEC 17025:2017 accreditation for mechanical testing and ISO 9001:2015 certification for quality management. The company offers a wide range of services, including mechanical testing with detailed reports, global regulatory consulting for FDA and EU submissions, and tailored engineering and R&D services for medical device design. Empirical Technologies also provides additive manufacturing analysis and custom protocol creation to meet specific client needs. With a focus on quality, integrity, and customer service, the company supports medical device manufacturers from prototyping through testing and regulatory approval, ensuring efficient project outcomes. Following a recent merger with ATS, Empirical continues to enhance its capabilities while prioritizing client support.

Technologies

Mimecast Outlook Microsoft Office 365 Google Font API Gravity Forms reCAPTCHA WordPress.org Mobile Friendly Google Tag Manager Remote

Keywords

medical device testing mechanical testing regulatory clearance eu mdr support regulatory consulting 510 submission medical equipment manufacturing test report generation quality assurance global testing services product testing industry accreditation regulatory consulting expertise testing laboratories and services test report accuracy regulatory compliance client partnership regulatory strategy manufacturing custom testing protocols eu mdr implementation support test report fast-tracking comprehensive mechanical testing global market support regulatory guidance iso 17025:2017 medical device testing services test protocol development medical device industry fda 510(k) submission success

Location

4628 Northpark Dr, Colorado Springs, Colorado, United States, 80918

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