The readers of MedTech Intelligence continue to crave any content that will help them learn more about the Medical Device Regulation.
Advanced manufacturing technology in the here and now.
Here’s what companies think when it comes to how much it will cost to comply with the new regulation.
With the evolution of medical electric technology, EMC concerns are crucial.
Getting your requirements right early in the development process can help avoid problems during final manufacturing.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
An infographic that shows advanced tools making imaging safer and more effective.
Although many device companies are seeking cost savings when seeking sourcing products or components manufactured in Asia, quality should not be compromised. Intense due diligence is important.
The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
The device is indicated for patients who have advanced heart failure and are not eligible for a transplant.