When designing and developing a medical device, companies often consider labeling down the road, but they shouldn’t, says Michael Drues, a regulatory consultant based outside Boston.
Labeling can involve a variety of ways a medtech company markets a product. What Drues calls high-level labeling – indications for use, intended use and label claims – drives to the heart of a company’s regulatory strategy.
“High-level labeling will directly impact your regulatory strategy and your pathway to market,” Drues said.
Read and listen to the whole story on our sister site, Medical Design & Outsourcing
The post Medical device labeling: You need to design it, too appeared first on MassDevice.
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