An Assorted Pick

Tracy Eberly
Medical Device

A Summary of Medical Device Regulation

The primary institution responsible for approving and regulating medical devices in the US is the Food and Drug Administration (the FDA). The FDA has created…
Tracy Eberly
Regulatory Affairs

How To Determine Whether Your Product Is a Regulated Medical Device

Not all devices are regulated equally, but oftentimes the line isn’t very clear for medical devices. Medical devices can range from very simple to incredibly…
Tracy Eberly
Medical Device

Common Medical Device Manufacturing Mistakes

No industrial manufacturer is perfect. For medical device manufacturers, there are many pitfalls surrounding product developments. There are many common mistakes medical device manufacturers make.…

Medical Device Consulting

Comprehensive Strategy

Defective medical devices jeopardize the wellbeing of patients and users and have extensive consequences for the manufacturers. Because of past occurrences, regulatory requirements have been intensified and the execution of existing regulations and criteria is being performed more strictly. Based in Minneapolis, Tracy Eberly provides the compliance knowledge needed for guaranteeing that safety and quality are preserved within the medical device niche.

Get Your Device To Market

Tracy uses experience to act as your medical device consultant and help address important regulatory and quality issues. He understands the ever-changing regulatory affairs for medical devices, and is accountable for hundreds of effective submissions. His standing in the industry makes it possible to offer medical device consulting based on decades of experience. His services focus on the most recent industry requirements.

Contact Us Today

Tracy’s wide-ranging services address all of the responsibilities and labor related to medical device regulatory submissions, quality systems regulations and fulfillment requirements. He can assist with both urgent and ongoing medical device consulting to take care of project outcomes and product fulfillment. He will work closely with your team to advance your projects from beginning to end. Call Tracy at 612-716-1209 to learn more today!