Whitepapers - Process control and monitoring

  • eMDR is Coming: How to Enhance Collaboration with the FDA

    EtQ, Inc.


    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...

  • Traceability as Opportunity

    Dassault Systemes


    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.

  • Are You Prepared for EN ISO 14971

    Noblitt & Rueland


    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...

  • Three Key Areas to Reduce Costs with Lean Techniques

    Epicor Software Corporation


    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...