The field of medical devices currently holds a market value of roughly $177 billion, and it's expected to grow at a 5% rate. Whether you run a sleep apnea clinic, dental practice, or family physician business, you are relying on medical devices and equipment to carry you through. By taking the best care of your medical equipment, you'll be able to get results and take optimal care of your patients. In this article, you'll learn more about medical device quality system auditing so that you can keep up with these machines.
What is medical device quality auditing and why is it important?
In the United States, the Food and Drug Administration (FDA) lays out the protocols and requirements for the way medical device quality audits are carried out. Outside of making sure that your devices are running with high quality, these audits are set up to make sure that your equipment is legally compliant. If your medical equipment fails legal compliance testing, you aren't giving your patients the best standard of care, and you might also run into situations that get you fined or shut down. This can have a ripple effect on your business since it will cause you to lose revenue and potentially tarnish your reputation with your public.
There are a number of reasons that you might get an audit. For instance, you might get hit with an external audit by your local governing body to make sure your company is in compliance. The manufacturer of the machinery that you're operating may also conduct an audit to make certain that their machinery is being used properly, and to cover their bases to make sure they don't need to conduct a recall for faulty machinery. It also makes sense to sometimes conduct an internal audit to get in front of any compliance problems.
Have you found a medical device company that can assist you?
If you need to conduct an internal audit, make sure that you reach out to professionals that can handle it for you. Consult with a company that provides medical device quality system auditing services and run through their protocols to find out what is included with each appointment. Get a point-by-point checklist, and also find out the company's credentials and how long they've been providing their services. Most importantly, make sure that you're ready to make any required changes if necessary.
Start with these tips and push toward getting an audit today. For more information, contact a medical device quality system auditing service.