A guide to ethylene oxide validation.
Whitepaper Tease
Overview of Gamma Irradiation Validation
A step-by-step guide to Gamma Irradiation Validation.
Medical Device Product Launches: Issues & Answers About Timing
The secrets to a successful medical device product launch from a public relations perspective
Communicating financial value when customers are only worried about reimbursement
A how-to guide to selling the financial value of your medical device to the hospital decision-making tree.
Successful medical device development: Critical Factors
A look at the critical business issues companies need to address when developing medical devices.
Patient Registries
The primary focus of this article is on patient registries designed to evaluate patient outcomes that include at least one of the following: disease progression, cost effectiveness, clinical effectiveness, safety, and/or quality of care.
Human Factors and Usability in Medical Devices
Human Factors Engineering (HFE), also known as usability engineering or ergonomics, is the study of how humans interact with machines and complex systems. As medical devices are becoming more complex human factors considerations are becoming more complex, this paper looks at some of the critical factors in helping medical device companies reduce human error in designing medical equipment.
FDA Inspection Trends
The FDA is implementing several new initiatives to maintain better oversight of contract research organizations conducting clinical trials. This paper looks at some of those changes in detail.
FDA Review Patterns of De Novo Submissions
The objective of this analysis was to assess whether timelines associated with the De Novo Process are in line with FDA’s stated goals.
Ground Bond vs. Ground Continuity: Why choose one test over the other?
Trends in the purchase of test equipment indicate that production line electrical safety is moving away from the traditional ground continuity test in favor of a ground bond test. This paper examines the differences between the two tests.
Why U.S. Medical Device companies should consider partnering with companies in India
A look at the advantages of using outsourcing partners in India.
