Magnetic resonance imaging (MRI) helps discover serious threats early and in a precise and painless way. However, patient safety may be in danger when medical implants interact with the electromagnetic environment. The developers of such implants are obliged to check the safety of their products under these conditions.
The dramatic increase of medical devices in patient care has yielded many benefits. However, this technology also carries various risks, including risks to patient privacy, that must be addressed.
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
In spite of continuing delays to implementation deadlines for EU MDR/IVDR, post-market surveillance requirements are currently in force. Hence, manufacturers need to urgently establish a PMS system to identify potential nonconformances and safeguard users and patients.
IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.
Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.
The Food and Drug Omnibus Reform Act (FDORA) authorized FDA to conduct remote device facility inspections. While it will take time for the FDA to take the necessary steps to start performing remote inspections, industry can look to remote regulatory assessments as a potential model.
Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators.
New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
Cybersecurity in health care is anything but simple. But significant changes can be expected in the coming years.
