Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
There are several tactical approaches to design that can help medtech manufacturers inspire patient confidence in their products and ensure proper usage. Following are three ways you can help ease the burden of delivering and receiving quality care through product design.
As 3D printing gains a more prominent place in the manufacture and protoyping of medical devices, advances in technology and materials are expanding indications. We spoke with John Kawola, CEO of Boston Micro Fabrication (BMF), about the move toward micro 3D printing and how this technology is supporting the drive for miniaturization and minimally invasive medical treatments.
Medical technology companies are caught between rising costs and increasing inflation as well as stricter regulations due to the introduction of the EU Medical Device Regulation. A strategic price adjustment can help to face these challenges and secure the companies’ success in the long term.
Connected devices already enable remote patient monitoring by collecting real-time data, such as injection date and time. With time, these benefits are likely to grow. Following are three areas where manufacturers are exploring new uses of digitalization in drug delivery to better understand the needs of patients and healthcare professionals and create more effective devices.
“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.
