Medical Device Link.

OUTSTANDING QUALITY AND REGULATORY TEAMS

Quality and regulatory professionals are the unsung heroes of a medical device company. Like baseball umpires, they only tend to get noticed when something goes wrong. But no medical product can be successful if the quality and regulatory personnel don’t do their jobs properly.

Thus, MD&DI decided to cite some quality and regulatory teams that are doing things right. The following pages contain profiles of eight teams whose contributions in the quality and regulatory arenas have been essential to the success of their companies’ products (or their clients’ products).

On the quality end, many of these teams have unusual systems in place that have produced excellent results that the rest of industry might be able to learn from. How do you set up a quality system? How do you learn from previous mistakes? How do you draft appropriate standard operating procedures? These tales may give you some ideas.

On the regulatory end, many of these teams were successful because they took the initiative to interact with regulatory agencies instead of sitting back and waiting for a judgment. There is a fine line between being active and being pushy, and these teams know how to stay on the right side of it.

So, while these accomplishments may not sound as sexy as those of an inventor or top salesperson, they are every bit as worthy of being recognized. We hope you enjoy the stories.

The Teams

• AtriCure Inc.
• Baxa Corp.
• Cholestech Corp.
• Ethicon Inc.
• Life Recovery Systems
• Plexus Electronic Assembly
• Stereotaxis Inc.
• US Endoscopy