The long-awaited part 23 of ISO 10993, the series of standards governing Biological Evaluation of Medical Devices, was published in January 2021. It was the first to introduce validated methods for in-vitro irritation tests. This article reviews the latest developments and identifies the cases in which manufacturers can avoid animal experiments.
Experts will explore how digital technologies have opened up new opportunities for patients, providers and medtech manufacturers.
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks), effective (performing as expected), and state of the art (compared to industry benchmarks).
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
The total $8.4 billion fiscal year 2023 budget request is 34% higher than the agency’s 2022 appropriated funding level.
The combination of medtech progress with strides in modern healthcare interoperability will enable preventive care in unprecedented ways.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Some of the company’s V60 and V60 Plus ventilators were assembled with an expired adhesive, which could cause product failure.
This year, the healthcare industry will step up its fight against cyberattacks because the costs and risks to patient care are becoming too great.
There is significant opportunity to develop therapies that create new standards of care and initiate a new wave of precision medicine.
