How in touch are you with current MDR guidelines?
There is a risk that the delivery wire could break or separate during use, being left inside the patient’s bloodstream as a result.
Why does anyone want to hack a medical device or steal medical data? The risk may appear low, but unfortunately this is not the case.
The report discusses the quality, safety and effectiveness of medical device servicing by OEMs and third parties.
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk.
All equipment must be qualified and calibrated for its intended use.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
Access to the IVD market in China is lengthy and complicated.
Can your company prove its device has been manufactured in accordance with its DMR?
When applicable, the process provides novel products with a speedier route to market.