Empirical Technologies

Empirical Technologies Corporation is a medical device testing laboratory and regulatory consulting firm that merged operations with Applied Technical Services (ATS) in 2022. Founded in 1998, the company specializes in mechanical testing for medical devices with ISO/IEC 17025:2017 accreditation from A2LA covering testing from head to toe (excluding cardiovascular devices).

The company operates three divisions: Empirical Testing (established 1998), Empirical Machine (established 2007), and Empirical Consulting (established 2013). Their testing capabilities include over 30 test frames for axial and torsional testing, spinal and small implant wear testing, additive manufacturing validation, and custom protocol development. The consulting division focuses on FDA 510(k) submissions, Design History Files, ISO 13485 gap analysis, and EU MDR implementation support.

With over 25 years of specialized experience, Empirical has completed more than 250 FDA clearances since 2013, with submissions clearing 20-30% faster than industry averages. The company actively participates in ASTM and ISO standards development and has conducted multiple FDA educational seminars.

Choose Empirical Technologies when you need an integrated partner for medical device development that combines machining, testing, and regulatory expertise. The company excels in scenarios where accelerated FDA clearance timelines are critical, having demonstrated consistent success with submissions clearing significantly faster than industry benchmarks.

Expect a consultative approach with emphasis on performing only necessary tests to avoid redundancy. Their accredited testing scope, combined with regulatory consulting from former FDA personnel, provides confidence for manufacturers navigating complex submission requirements for orthopedic and spinal devices.

Empirical Technologies exclusively serves the medical device sector with specialized focus on implantable devices for orthopedic, spinal, trauma, and general surgical applications. Their healthcare expertise encompasses FDA 510(k) and PMA regulatory pathways, ISO 13485 quality system requirements, and EU MDR compliance for international markets.

The company's healthcare vertical specialization includes comprehensive understanding of ASTM and ISO testing standards specific to medical devices, sterilization validation, biocompatibility testing coordination, and Design History File documentation requirements. Their team's active involvement in medical device standards development positions them as technical authorities in mechanical testing protocols.

Medical device companies in development or commercialization stages requiring mechanical testing for orthopedic, spinal, or general surgical implants. Companies prioritizing speed to market through FDA 510(k) pathways, particularly those needing guidance on test protocol development and submission strategy. Firms seeking a single partner for prototype machining, validation testing, and regulatory documentation rather than managing multiple vendors.