Sep 1
Qualifying Medical Device Development Tools (MDDT)
The US Food and Drug Administration (FDA)’s voluntary Qualification of Medical Device Development Tools (fda.gov) is intended to encourage use of innovative technologies and novel approaches to medical device development and create a favourable regulatory framework to expand the availability of entirely new medical devices to patients.
This blog includes an overview of MDDT program, its categories, history, benefits, Centre for Devices and Radiological Health (CDRH) Qualification Process and Decision Framework.
Continue reading »
As you gear up to face your impending FDA inspection, we’re here to lend a helping hand with five crucial tips for a smooth and successful FDA inspection.
When thinking about the roles of Quality Assurance (QA) and Regulatory Affairs (RA), I like to use the metaphor of the trail blazer and the guide, RA is there to blaze the trail and find the path, QA is there to keep the team on that path and away from pitfalls and hazards.
Our employee experts share their best tips and examples for each phase of the commercialization process in a four-part series on Medical Device Commercialization. This blog covers Medical Device Phase One Product Development engineering, design and development. For Phase Zero tips, check out our blog on 
Human factors validation testing is the final usability testing to be completed prior to regulatory submission. A mistake or an omission may result in follow-up testing being required if you uncover unanticipated use errors during testing. Careful planning is highly recommended.
Patient-centered design is designing healthcare with the patient in mind, a methodology that prioritizes the patient’s desires and requirements. This encompasses constructing medical facilities, procedures, and systems to enhance patient care. The concept of patient-centered has gained considerable traction in recent years as healthcare organizations worldwide strive to improve their quality of care.
Medical devices play a vital role in modern healthcare, aiding in the diagnosis, treatment, and management of various medical conditions. However, the effectiveness and safety of these devices rely not only on technological advancements but also on their usability and compatibility with human factors. 
Microfluidic point-of-care assays are a hot topic nowadays and there’s lots of buzz surrounding how to make inexpensive, quick and reliable cartridges. 
Medical device projects generally have an 
Medical