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.
This year, the healthcare industry will step up its fight against cyberattacks because the costs and risks to patient care are becoming too great.
A global pandemic is still upon us, but that certainly does not mean that healthcare technology innovation is standing still. To help the medical device industry look to the future and prepare, experts from regulation and academia alike are bringing attention to the acceleration and pitfalls of innovation.
This article highlights what manufacturers should prioritize and areas in which new information may still emerge, along with providing a starting point for businesses that need to familiarize themselves with the UK Conformity Assessed marking requirements.
To change the landscape of cyber threats in healthcare, companies must prioritize designing security into devices.
The key is to keep quality high and risk low.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.
Moving too quickly in the product development process can lead to mistakes.