Top Medical Device Testing and Certification Companies - 2020
Test O Pac Industries Inc.: Where Safety Meets Successful Packaging

Top 10 Medical Device Testing and Certification Companies - 2020

Medical equipment manufacturing industry has always been on the forefront of all discussions relating to the overall growth of the healthcare realm. Lately, the industry has been investing highly on novel equipment to help doctors offer better patient care. For instance, today, specialized catheters are being used to make open heart surgeries safer. The agenda is to ensure speedy recovery of patients, while also reducing their re-admission rates.

A recent trend in medical equipment manufacturing is working on medical devices that can help patients to cope with illegal drug addiction. In addition, today, the treatment of depression and other mental health illnesses are also being included as a significant upgrade for various brain stimulation devices. Other smart devices and wearables are becoming more and more instrumental in keeping a close check on patients and recording their vital signs on a timely basis.

The domain of medical equipment manufacturing is indeed opening new doors for expansion for healthcare. At this juncture, there is a wide variety of medical device manufacturing solutions providers entering the landscape with a set of advanced offerings. To help companies strengthen their infrastructure and simultaneously grow, MedTech Outlook has compiled a list of ‘Top 10 Medical Device Testing and Certification Companies - 2020.’ Besides, the magazine also comprises insights from industry thought leaders on the various industry trends, best practices, recent innovations, and their advice for the aspiring CXOs.

We present to you MedTech Outlook’s, “Top 10 Medical Device Testing and Certification Companies - 2020.”

    Top Medical Device Testing and Certification Companies

    EdgeOne Medical
    EdgeOne provides critical product development support throughout the development and life cycle management of medical devices/combination products including testing and certification. Led by product development professionals, the company provides an ISO 13485 certified and FDA compliant Medical Device Testing Lab that can operate according to global requirements. Further, EdgeOne provides cross-functional product development experts who work as an extension of the client’s team and resources designed for the development life cycle. Apart from its testing services, clients utilize the company’s diverse capabilities in the product development lifecycle, including quality management, regulatory needs, remediation, and project management
    EKG Life Science Solutions
    The company is an analytical laboratory that supports medical device and pharmaceutical companies seeking to fast-track their product development. As a certified woman-owned business, operating within facilities that are FDA audited and DEA approved for substances scheduled I-V, the company’s analytical expertise includes extractables and leachables programs, impurity identification, material compatibility, chemical characterization, and method development, optimization, and/or validation. EKG Labs is an industry expert in offering medical device development support services to support 510(k) and PMA filings. EKG Labs’ team also has extensive experience in drug-device testing (combination product testing).
    Test O Pac Industries Inc.
    Delivering package validation testing solutions for medical device manufacturers, helping them gain an adequate and effective package design
    BDC Laboratories
    The mission of BDC Laboratories is to offer products and services to the medical device industry that aid in functional evaluation of technologies as related to clinical outcomes. Biomedical Device Consultants was formed in 1977 by Dr. Steven Weinberg as a consulting company, to provide general R&D services to the medical device industry. To meet the needs of BDC’s domestic and international clients, a GLP engineering testing laboratory was established in 1985. By combining the laboratory and consulting services within a single company, the clients of BDC Labs obtain the benefits of over 30 years of medical device development and testing experience in one company. In 2006, Dr. Craig Weinberg joined the company bringing an influx of new energy and technology to the business. In 2007, a second facility was opened in Wheat Ridge, Colorado to accommodate the expanding capabilities and business. From this foundation, along with our highly technical personnel, BDC Labs is capable of providing support in all aspects of product development and evaluation for developmental and regulatory activities
    F2 Labs
    F2 Labs is an accredited, full service product conformity assessment organization founded in 1991. We have safety and EMC testing facilities located in Maryland, Indiana and Ohio. We offer a variety of services including Safety, EMC, IP, NEMA, Performance, UL, CSA, CE testing, and are accredited by the American Association for Laboratory Accreditation (A2LA). With the A2LA accreditation and further approvals, we are able to provide testing/certification of products for the FCC, Industry Canada, European CE, Australian Communication Authority (ACA), North American/Canadian Safety approvals, and much more; providing your company the tools to access world markets through product compliance
    Foster Corporation
    For more than thirty years Foster Corporation has been serving medical device manufacturers with industry leading technology and service in custom biomedical polymer compounding. Within three ISO 13485:2016 certified facilities, Foster offers expert formulation development and production of polymer enhancements including radiopaque fillers, custom colors, and other specialty additives. Custom formulations support class I, II and III medical device applications. Foster Corporation also operates two additional business units, including Foster Delivery Science, Inc. and Foster Polymer Distribution
    Intertek
    Intertek is a leading Total Quality Assurance provider to industries worldwide. For more than 130 years, companies around the world have depended on Intertek to help ensure the quality and safety of their products, processes and systems. Our network of more than 1,000 laboratories and offices and over 46,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains
    PharmEng Technology
    PharmEng Technology is a global full service consulting firm that serves pharmaceutical, biotechnology, and medical device industries. Since 1997, the company has provided industry-recognized services to assist clients in the rapid commercialization of new products from drug discovery, strategic planning to process scale up. PharmEng Technology prides itself in its proven track record of excellence which ensures all client needs and governing regulatory expectations are met and exceeded
    Registrar Corp
    Registrar Corp provides U.S. FDA registration, U.S. agent, and regulatory compliance assistance for U.S. and non-U.S. companies in the food and beverage, medical device, drug, cosmetics, and radiation-emitting device industries. Registrar Corp provides expert assistance in 19 different languages, 24 hours per day, 7 days per week. Registrar Corp was founded in 2003 to assist businesses with compliance with U.S. Food and Drug Administration (U.S. FDA) regulations. Since opening its headquarters in Hampton, Virginia, USA, Registrar Corp has expanded to nineteen international offices and has aided more than 20,000 companies across 150 countries. Employees include former U.S. FDA officials, scientists, and industry experts
    UX Firm
    UX Firm is a usability consulting company engaged in usability testing and many other types of UX research with clients world-wide. With our mobile lab, we can reach your users wherever they are, in person or remotely. We can also set up our lab at your offices. We’re experienced user researchers. We’re veterans in the UX field. We’ve been doing usability research for decades. We bring our business and academic backgrounds together to provide practical, research-based solutions for every project

Medical Equipment Info

Q1
What Do Top Medical Equipment Companies Do?
Top Medical Equipment Companies design, manufacture, distribute, service or support equipment used across hospitals, outpatient centers, specialty clinics and care facilities. Their scope may include diagnostic systems, monitoring tools, surgical equipment, therapeutic devices, mobility products and maintenance services. In a listing context, the category is less about a single product line and more about how companies help care teams keep equipment available, accurate, safe and compliant. Strong medical equipment companies understand clinical workflows, procurement limits, service response times and the documentation requirements tied to regulated healthcare environments.
Q2
Why Do Medical Equipment Companies Matter Now?
Top Medical Equipment Companies matter because healthcare providers are under pressure to extend equipment life, reduce downtime and improve care access without adding avoidable cost. Demand is shaped by aging populations, higher procedure volumes, outpatient care growth and the rising dependence on connected devices. Medical equipment vendors are also being judged on cybersecurity, service coverage and lifecycle support, not just product availability. For hospitals, a delayed repair, missing part or poorly integrated device can affect scheduling, staff productivity and patient throughput.
Q3
How Should Healthcare Decision-Makers Evaluate Medical Equipment Companies?
Evaluation should start with fit: the equipment category, clinical setting, expected utilization and support burden. Buyers should examine quality certifications, repair networks, parts availability, training programs, installation support and response commitments. Top Medical Equipment Companies also need clear documentation practices, transparent pricing and experience with healthcare compliance. For capital equipment, decision-makers should look beyond purchase price to maintenance costs, software updates, calibration needs and useful life. Healthcare equipment providers that can support both procurement and post-sale service usually carry less long-term risk.
Q4
What Value Do Leading Medical Equipment Providers Create for Care Teams?
Trustworthy equipment can significantly alter the flow of care. It can reduce procedure cancellations, limit delays to diagnosis, improve patient observations, and allow for smoother workflows with fewer interruptions. Top Medical Equipment Companies bring value when their equipment functions reliably and when the service department is able to prevent small failures from causing an entire department-wide work stoppage. Business benefits will include lowered rental fees, increased asset utilization, and minimized expenditures on emergency solutions. Care benefits include more immediate results, where clinicians are not having to wait hours to gain access to the proper equipment to treat patients when they need care.
Q5
How Are Technology and Service Expertise Changing the Medical Equipment Landscape?
Technology is changing what healthcare providers expect from medical equipment vendors. Devices are now connected to hospital networks, asset management systems and electronic records, making cybersecurity, software reliability and data accuracy just as important as hardware performance. Service support has also become more complex. Technicians often need to manage calibration records, preventive maintenance schedules, firmware updates and audit documentation alongside equipment repairs. Many providers now use remote monitoring and analytics to identify issues before equipment fails. But hospitals and care teams still need to evaluate whether those tools genuinely improve repair response times, increase inventory visibility or reduce the workload placed on clinical and technical staff.
Q6
What Should Healthcare Organizations Prioritize When Comparing Medical Equipment Companies?
Healthcare organizations should compare Top Medical Equipment Companies by reliability, service depth, compliance readiness, user training and total cost across the equipment lifecycle. A lower upfront price can lose value if parts are scarce, maintenance is slow or staff need repeated retraining. Medical equipment vendors should be able to explain warranty terms, replacement timelines, cybersecurity responsibilities and escalation paths in plain language. For critical care areas, labs, imaging suites and surgical departments, provider reliability is not an abstract quality. It shows up in schedules, patient flow and staff confidence.