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.
Tag Archives: risk
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.
Liability Risks and Litigation Defenses for COVID-19 Tests: Five Lessons from Past Product Misdiagnosis Cases
Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.
Liability Risks and Litigation Defenses for COVID-19 Tests: Potential Claims and Defenses
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
Managing Testing Strategies Under the EU MDR
Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy.
Playing by the Rules: A Lever for Doing Better Business?
Investments in new processes and systems must satisfy the needs of the authorities and ensure patient safety and public confidence. Getting it right is likely to be expensive. but regulatory compliance shouldn’t be viewed purely as a cost center.
