The Food and Drug Administration (FDA) is tasked with the job of ensuring that all products produced within medical device, food and beverage, pharmaceuticals, biologics, and all other industries encompassed within the...
Can medical device makers re-frame shifting regulatory compliance needs to create business improvement? Yes. Some are already doing it. It's essential other companies join them or risk falling behind.
The updated “EN ISO 14971:2012 Medical Devices – Application of risk management to medical devices” standard was published August 30, 2012 in the Official Journal as harmonized to the Medical Device Directive, Active...
While the principles behind lean techniques can be applied to nearly any business, the term “lean” is most often associated with process improvement and cost reduction in manufacturing. Most businesses ascribe to the...