“The innovation, security and reliability of AWS helps us accelerate the delivery of high-quality clinical documentation. Our overarching goal is to create a better, more sustainable solution and to continue to be a trusted partner that our clients can rely on to reduce administrative tasks and prioritize patient engagement.”
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.
Selecting a strong medical device contract manufacturer is critical to ensure supply chain resiliency, regulatory compliance, and long-term success for a medical device OEM. This article is a guide to the most important questions to ask yourself and your contract manufacturer to help ensure a successful partnership.
Business strategy and forecasting influence several functional areas within an organization, including R&D, pipeline planning, revenue planning, inventory, resource and budget allocation, project prioritization, compensation plans, market access efforts, and more. These varied uses reflect the first major challenge of forecasting: meeting the needs of varied and diverse stakeholders. Following are three steps to make your forecasting efforts more effective.
The nonclinical assessment model (NAM) can predict the rise and distribution of temperature in bone around metallic femoral nails when exposed to radio frequencies during an MRI scan.
MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems, and device manufacturers are faced with significant challenges in bringing these connected solutions to market. Slow and expensive development lifecycles, complex and inflexible device architectures, and the need for increased cybersecurity, are among the key challenges. The solution lies in a new generation of devices powered by intelligent software data flow.
On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
UX (user experience) design processes are constantly evolving as the industry continues to embrace IoT technologies. With this evolution comes a need to focus on improving UX protocols in the design of medical devices.
Cybersecurity in health care is anything but simple. But significant changes can be expected in the coming years.
Hägen, who was a contributor to Medtech Intelligence, spent 28 years building BlackHägen Design to support clients in the development of “mission-critical” products. He was pivotal in the advocacy of human factors and good design practices for medical devices and was at the forefront of patient safety initiatives, helping to found the Industrial Designers Society of America (IDSA) Patient Safety Committee.
