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Heath science and health services research company
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$50 - $99/hr
50 - 249
United States
PEGUS Research Inc, is a full service heath science and health services research company. •We can help you find creative solutions to research problems •We have experience and expertise in epidemiology, survey, and observational research •We serve the pharmaceutical industry and specialize in studies that support Rx-to-OTC switches, as well as consumer products clients, and a variety of other health-care organizations
Explore PEGUS Research office locations and service areas.
331 S Rio Grande St Suite 100 Salt Lake City Utah United States 84101
(801) 487-9899
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What is the primary focus of PEGUS Research?
PEGUS Research is a clinical research organization that specializes in human factors and usability engineering. The company focuses on evaluating the safety and effectiveness of medical devices, combination products, and pharmaceutical delivery systems to ensure they meet regulatory requirements and user needs.
What specific services does PEGUS Research provide?
Services include formative and summative usability studies, user interface design support, risk assessment, and regulatory submission support. The team assists clients in navigating the FDA and international regulatory pathways by providing expert guidance on human factors engineering processes throughout the product development lifecycle.
Which industries does PEGUS Research serve?
The company primarily serves the medical device, pharmaceutical, and biotechnology industries. It works with organizations developing complex medical products that require rigorous human factors testing to ensure patient safety and regulatory compliance.
Where is PEGUS Research located?
The company is headquartered in Salt Lake City, Utah. This facility is equipped with specialized labs designed to simulate real-world clinical environments for testing medical devices and drug delivery systems.
How does PEGUS Research support regulatory submissions?
The firm provides comprehensive support for FDA 510(k), PMA, and De Novo submissions. By conducting validated human factors studies and documenting the usability engineering process, the company helps clients demonstrate that their products can be used safely and effectively by the intended user population.
What is the background of the PEGUS Research team?
The team consists of human factors engineers, clinical researchers, and regulatory specialists. Many staff members have extensive experience in medical device development and hold advanced degrees in fields related to human factors, psychology, and engineering, allowing for a multidisciplinary approach to product testing.
Does PEGUS Research conduct formative usability studies?
Yes, formative studies are a core part of the development process. These studies are conducted early and throughout the design phase to identify potential use errors, inform design improvements, and reduce risks before the final summative validation study.
What is the role of the usability lab at PEGUS Research?
The on-site usability lab provides a controlled environment that mimics clinical settings, such as hospitals, clinics, or home-care environments. This allows researchers to observe how users interact with medical devices in realistic scenarios, ensuring that data collected is accurate and representative of actual use.
How does the company address risk management in medical devices?
Risk management is integrated into the usability engineering process. By identifying potential use errors early, the team helps clients implement design mitigations that reduce the likelihood of harm, ensuring compliance with standards like IEC 62366 and FDA guidance documents.
Can PEGUS Research assist with global regulatory requirements?
Yes, the company is well-versed in international standards and regulatory requirements, including those from the FDA, EMA, and other global health authorities. The team helps ensure that usability data meets the specific expectations of various regulatory bodies worldwide.
How can a company contact PEGUS Research to discuss a project?
Interested parties can reach out through the contact form available on the official website. The site provides a dedicated contact section where potential clients can submit inquiries regarding their specific medical device or pharmaceutical delivery project needs.
Does PEGUS Research work with both startups and large enterprises?
The company works with a wide range of clients, from small startups to large multinational corporations. The services are scalable to meet the needs of different project sizes, whether a client is in the early prototype stage or preparing for a final regulatory submission.
What is the typical approach to a human factors study?
The process typically involves defining the user population, identifying critical tasks, conducting iterative testing, and documenting the results. This structured approach ensures that all human factors activities are aligned with the client’s product development timeline and regulatory goals.
Does the company provide support for combination products?
Yes, the company has significant expertise in combination products, which integrate drugs or biologics with medical devices. These products often present unique usability challenges, and the team specializes in navigating the complex regulatory landscape associated with these devices.
How does PEGUS Research ensure the quality of its research?
Quality is maintained through adherence to rigorous internal protocols and international standards for human factors engineering. The company emphasizes data integrity, detailed documentation, and objective analysis to ensure that all findings are defensible during regulatory audits.
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