One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
The acquisition expands Veranex’s European footprint as well as the scale and scope of its clinical studies capabilities.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to concerns raised by medical device trade associations regarding future regulation of medical devices in the United Kingdom.
The partnership brings together Evidence Partners’ literature review platform, DistillerSR, and Akra Team’s strategic regulatory services.
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
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.
Simplifying the PMS process globally from end to end, can help medtech companies realize significant improvements across the board while keeping operating costs under control.
A recap of a recent effort involving a small group of AIDC experts in devising a data integrity scheme suitable for protecting a new device identifier used in modern healthcare applications against mis-keying. It presents the group’s undertakings in researching solutions to ensure identifier integrity, the challenges encountered, and how a more complete understanding of the constraints of the intended application led to a departure from the initial design and resulted in the elegant solution that exists today.
The outlook for 2020 and beyond is positive, but medical device companies must continue to evolve their technologies and partnerships to keep the attention of investors.
When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.