Healthcare & Medical
Device Testing

Medical device testing is an integral step in developing an innovative idea into an efficient and marketable product meeting regulatory standards. The FDA’s Center for Devices and Radiological Health (CDRH) regulates entities that build, repackage, relabel, and import medical devices marketed and sold in the US. With revelations that a whopping 69 percent of 501(K) submissions to the FDA are rejected the first time, you need a robust preparation strategy to increase your clearance rates. A significant portion of your preparation involves product testing to demonstrate compliance with standards and regulations worldwide.

At Compliance Testing, we leverage expert medical product testing knowledge and state-of-the-art internationally accredited laboratories and facilities to offer you cost-effective one-stop testing solutions that help get your product to the market quickly. Our testing services are designed to cover your full design and product cycles right from prototype testing, functional safety, and security assessment, environmental monitoring, performance testing, toxicity and chemical analysis, and pre-shipments inspections, among others.

Compliance Testing Provides a Range of Healthcare and Medical Testing Services

As a leading provider of healthcare and medical device testing solutions in the US, Compliance Testing has over 50 years of experience providing top-notch end-to-end assurance solutions, testing, inspection, and certification for various Healthcare and Medical Device manufacturers globally. The specific areas that our testing solutions focus on include:

Testing for MedTech

Recent studies reveal the global medical devices market is projected to grow from $455.34 billion in 2021 to $657.98 billion in 2028 at a CAGR of 5.4% in the forecast period. Bringing an innovative medical device technology to the market can be a challenging and high-risk investment. Compliance Testing is committed to supporting every stage of your medical device testing. Whether you are a small start-up or a large and established manufacturer, our experts are committed to providing absolute testing certainty covering protocol development and prototype feasibility and guidance for 510(k), CE marking, and other regulatory submissions.

By choosing Compliance Testing as your comprehensive medical device tech testing partner, you will enjoy the perks that come with a single-source supplier for all your testing needs. We offer a complete suite of medical device testing that includes:

  • Feasibility and research & design
  • Product development
  • Production quality control
  • Material characterization and microbiological evaluation
  • Mechanical testing
  • Product testing

We work with a dedicated team of experts with years of experience offering a wide range of testing for Class, I, II, and III medical devices. Our testing solutions guarantee every critical part of your medical device’s product meets regulatory standards for faster approvals.

Importantly, our Medtech testing solutions cover the following specific medical devices and materials: chemical compatibility testing for medical device materials and services, reusable medical device validation, EMI&EMC testing, cardiovascular device testing, orthopedic implant testing, among others.

Testing for HealthTech

HealthTech refers to any technology, device, or digital solution designed to improve a patient’s health. As healthcare technology expands, new possibilities within the healthcare domain are opening rapidly. Advances, including open-source hardware and mobile phone apps, create massive opportunities for custom-made healthcare devices that provide personalized care. The FDA typically regulates the sale of Health tech device products in the US and monitors the safety of all regulated medical products. If you are a healthtech device manufacturer, partnering with a reliable and experienced medical device testing provider ensures your products receive approval in the shortest time possible.

At Compliance Testing, we help emerging and established wellness and healthcare product manufacturers meet the mandatory testing requirements to ensure faster approval and quicker time to the market. Our experts stay current on the ever-changing global regulatory environment to ensure the right type of product evaluations and testing is performed on your product according to the current classification.

We leverage our vast experience, state-of-the-art testing facilities, and digital solutions to customize our services and deliver a personalized approach to solve your healthtech compliance issues. Our testing services cover a wide range of areas from the design and development stages through manufacturing and delivery.

Testing for BioTech

Bringing new BioTech solutions to the market successfully can be a complex, time-consuming and costly process. The regulatory approval pathway demands substantial preclinical testing before biotechnology is approved for the market. At Compliance Testing, we leverage a systematic approach and solid testing protocols to navigate the challenging pathways successfully and get your biotech products to the market quickly and efficiently. Our BioTech testing services cover the following areas:

Preclinical development: We will help you understand the regulatory requirements through robust risk assessment, design studies and assessment. Our experts are ready to walk with you through every step in developing your biotech product, from prototyping to the approval stage. With over 50 years of experience in the preclinical testing field, and Compliance Testing is undoubtedly your trusted partner to help you meet all regulatory standards for timely market launch.

Quality and accuracy: Compliance Testing is accredited by the ANSI National Accreditation Board and provides unparalleled quality testing solutions that help thrust novel medical products into the market. Our operations are governed by rigorous quality management standards designed to ensure highly accurate and precise testing.

Top-notch equipment: Our state-of-the-art device testing facilities guarantee best-in-class preclinical safety and efficacy testing. In addition, our facilities are equipped with top-tier analytical instruments, cutting-edge technologies, and highly trained and experienced staff.

Testing for AthleticTech

There is no doubt technology is revolutionizing the world of athletes and spectators at sporting events. Advancements in technology both in the past and present have contributed to making the sport better for everyone. However, the utilization of this rapidly developing technology in sports has not been without controversy. Notably, any introductions or changes to equipment technology can influence how a sport is played or influence its performances, introduce unfairness, or safety issues.

As such, as an AthleticTech developer, you may need approvals before you take your product to the market. At Compliance testing, we will subject your product to a range of assessments to guarantee it is free of any severe ramifications for fairness, innovation, safety, and the integrity of sport. Our experts will seek to identify and fix all non-compliance through a series of evaluations and assessments. We are committed to providing the fastest turnaround for product safety testing and certification so that you can market the product.

Testing for Wearables

According to Statista the number of connected wearable devices globally has increased from 325 million in 2016 to 722 million in 2019. The number of devices is expected to reach more than one billion by 2022. The wearable devices market is primarily powered by massive growth in the sales of smartwatches and fitness trackers across the globe.

If you are a manufacturer of popular wearables, including smartwatches, fitness trackers, implantable medical devices, and more, there is a need for a thorough quality inspection before your product is allowed into the market.

At Compliance Testing, we will subject your wearable gadgets to outstanding testing that closely mimics real-life conditions to generate crucial insights into the gadget’s behavior. Some of the critical testing types that we provide including:

  • Functional testing: Wearable devices typically come with several features packed in a tiny space. Our functional testing ensures all these features are working as intended.
  • Connectivity testing: It is crucial to check and test the connection between software and hardware to guarantee the optimal performance of your device. Our experts will perform checks under different network conditions and interruptions.
  • UI testing: UI tests focus on buttons, touch sensors, checkboxes, and another graphic element that enhances the functionality and usability of your device. Our experts make sure all these components are working well in different environments.
  • Compatibility testing: Our experts will conduct cross-device, cross-browser, and cross-platform checks that verify your gadget is compatible with other devices.
  • Performance testing: It is essential to test for system flaws that could affect the performance of your device before it reaches the market. Our experts focus their tests on systems flaws that could affect CPU and memory usage, loading speed, and more to guarantee the system is running seamlessly.
  • Localization testing: Our experts will also check for language settings, formats, currency, and time and date formats to ensure your product fits well in different markets.
  • Acceptance testing: The final test that we will perform is acceptance testing. This test is intended to prove that your product meets all the regulatory requirements and is error-free.

Compliance Testing offers Trusted Product Safety Certification and Testing

If you are looking for a reliable partner to help you meet compliance requirements for all your health care and medical products, Compliance Testing, LLC has you covered. We provide best-in-class premium product safety testing and certifications designed to help you get your product to the market with ease. Once all tests are completed, we document the process comprehensively, using technical files, photos, construction reviews, and support documents. Contact us today to learn more.

We can answer your questions and let you know the costs associated with EMI/EMC testing and other compliance processes.