MD&DI's Outstanding Quality and Regulatory Teams
Scan the media for a sense of who gets the attention when a device company is in the news, and chances are you'll never see mention of a quality or regulatory person. In most cases, it'll be the CEO or the CFO. It could be the product's inventor. Sometimes it may be a top sales or marketing person. In perfunctory pieces, it's usually someone from corporate communications.
Yet quality and regulatory professionals deserve recognition because they 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.
The June issue of MD&DI rectifies that. We want you to notice some quality and regulatory teams that are doing things right. We profiled eight teams whose contributions in the quality and regulatory arenas have been essential to the success of their company's products (or their clients' products).
On the quality end, many of these teams have unusual systems in place. Such systems 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 a top salesperson, they are every bit as worthy of being recognized. We hope you enjoy their stories.
Outstanding Quality and Regulatory Teams
Balancing the Device World On Their Shoulders
By the editors of MD&DI
The achievements of quality and regulatory personnel are often overlooked—but they shouldn’t be. Here are some inspiring stories from quality and regulatory teams that have stood out in the industry.
Leakage-Current Testing for Patient-Monitoring Devices
By Jeff St. Onge
Learn the ins and outs of IEC 60601-2-49 for part-leakage-current testing.
Laser Welding: Metal Fastening with Microscopic Precision
By James Whitcher
Strong and light structures can be fabricated using laser-welding techniques on sheet metal.
Revising FDA: Fees, Mail Delays, Openness, Efficiency
By James G. Dickinson
CDRH's little inefficiencies lead to big industry headaches.
More from this issue of MD&DI