To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Medical device security needs to address the cyber-physical threats, not just patient health information risk.
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.
Physicians need technology that helps them track disease progression and response to therapy.
To achieve success in this market, device manufacturers should consider working with providers to help contain costs and enhance outcomes.
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.
Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.
Part one of this series looks at the claims brought against manufacturers of diagnostic test kits.
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.
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.