In this segment of Ask the Experts, James Thompson of Siemens responds to questions about how digital infrastructure is leading the way in medical device advancements and innovation.
A review of common risks and pitfalls of incorporating artificial intelligence in medical devices and an overview of the regulatory framework.
Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.
Moving too quickly in the product development process can lead to mistakes.
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.
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.
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.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
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.