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.
There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
Does your company understand the magnitude of the compliance effort?
The race to apply AI to medical treatment is rapidly accelerating in China and Japan.