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...
Choosing and Implementing an ERP Solution as the Core of a Quality System: Medical Device Manufacturers Share their Advice
White Paper Summary Choosing and implementing an ERP system is not a trivial task—especially for medical device manufacturers. Because it plays a central role in an overall quality system that must be validated...