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Medical Device Testing

Testing Medical Devices

Medical devices are often used in life-threatening situations, which means early medical testing is vital to ensuring safety and reliability. CPT℠ provides testing that follows the key regulations and industry standards set forth by the FDA and CDRH (The Center for Devices and Radiological Health).

The program developed by the CDRH highlights safe, reliable medical devices, in addition to radiation-emitting products and newly emerging technologies. The FDA also classifies medical devices based on their risk and efficacy.

There are currently around 1,700 different generic devices, grouped into 16 medical specialties, based on three classes. In order to assess real-world application, testing medical devices is critical based on key risk factors. CPT℠ tests medical devices from every classification. Our team of experts can evaluate everything from low-risk products to products that require the highest level of regulation. This includes operating tables, dental floss, hearing aids, external defibrillators and more.

pacemaker-medical-device-testing

How We Help Our Clients

At CPT℠, we offer a wide range of programs and services to meet the needs of our clients. When you seek early medical device testing, you can:

  • Detect potential vulnerabilities and risk factors. This is especially true regarding the safety of patients and the security of the device itself.
  • Gain assistance and guidance as you work through extensive and highly complex processes regarding regulations and documentation.
  • Seek proper testing based on class I, II and III devices, increasing the reliability of claims made — while reducing overall risk.

Depending on the medical device being tested, numerous departments may be involved.

Our Departments

Based on the individual needs of our clients, we offer a wide range of support across various departments. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:

  • Clinical — Efficacy trials can be performed for safety, consumer in-use, and to support claims such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.’
  • In-Vitro Toxicology — Our In-Vitro Toxicology department assists clients when they are looking to perform non-animal (animal-free) toxicology testing.
  • Microbiology — Microbial contamination and preservative efficacy testing are key to cosmetic and OTC drug products.
  • Photobiology — From SPF and Water-Resistant claims to Photoallergy and Phototoxicity studies, CPT℠ is the world leader in sunscreen testing.
  • Analytical — From raw materials, product batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our analytical department ensures that all requirements are met based on industry standards.
  • Consulting – Our consulting staff can perform GMP and GLP audits of your facilities or vendors, help create SOPs, develop testing programs, etc.

Get In Touch

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CPT℠ LABS

Corporate Headquarters and Labs
70 New Dutch Ln
Fairfield, NJ 07004
973-576-5957

Satellite Clinical Lab Location
304 Wootton St.
Boonton, NJ 07005

Registrations

FDA
Registration# 1000151293

CPT℠ is registered with FDA (FEI # 1000151293) as a Drug Establishment (GMP/GLP/GCP) and a Cosmetic Facility.

DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
Registration# RC0171568 (Researcher)

US EPA/NJ DEP
Registration# NJD982726648

ISO/IEC 17025:2017 Accredited