To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
Despite the high stakes of data vulnerabilities to the entire healthcare system, governments in Asia lag behind in mandating cybersecurity measures, leaving manufacturers to install and maintain systems to protect against cyber criminals.
Healthcare alliance group Premier discusses six issues that are at the forefront in the context of the 2020 election.
The pandemic is helping realize the potential of ISO IDMP data standards in relation to adverse event reporting, electronic prescribing and medicines control in the supply chain.
The PCR and real-time PCR molecular diagnostics was valued at $4 billion in 2019.
Adopting new technology to ensure the health and safety of patients shouldn’t adversely affect security and privacy.
Medical device security needs to address the cyber-physical threats, not just patient health information risk.
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous.
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.
The pandemic has revealed some inadequacies in the way medical device suppliers manage regulated product information. The following is a look back on a challenging year and suggestions for practical improvements to cope with continued uncertainty in 2021.