How to Achieve Quality through Process Validation
The key is to keep quality high and risk low.
Tag Archives: risk
MedTech Leads Industries in Recalls, Numbers Expected to Rise in 2021
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.
The Top Trend for Medical Devices in 2021? Putting Quality First
Moving too quickly in the product development process can lead to mistakes.
Designing the Worst-Case Test to Get Best Case Results
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Remote, Telehealth-Driven World Poses New Concerns for Medical Device Security
Medical device security needs to address the cyber-physical threats, not just patient health information risk.
Lack of Hospital Access Changes Med Device-Provider Interaction
Jennifer Fried, CEO of ExplORer Surgical, explains the stress that COVID-19 has placed on healthcare and the shift in how medical device reps are connecting with hospitals and healthcare providers.
Advancing the Biopsy: Biosensors as a More Accurate and Sensitive Disease State Diagnostic Tool
Physicians need technology that helps them track disease progression and response to therapy.
Population Health Solutions Can Improve Value-Based Quality Measures and Reporting During a Pandemic
To achieve success in this market, device manufacturers should consider working with providers to help contain costs and enhance outcomes.
Asia 2020 Device Regulatory Update
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
