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.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
When outsourcing these key functions, asking the right questions will help minimize the risk.
Look for the good, the bad, and the ugly, but above all, look for anything that affects patient safety.
All employees who handle patient information must be appropriately trained to HIPAA.
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.
As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is especially troubling given the financial challenges many hospitals face.