• Current Issues in Medical Device Risk Management

    29 July, 2014 by Edwin Bills, RAC Consultant

    Medical devices have been developed with some requirements for product safety since the implementation of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act.  Initially FDA required manufacturers to submit information related to safety as part of the 510(k) premarket notification process, providing comparative data on predicate devices versus the device under consideration.  In the more rigorous Premarket Approval (PMA) process, more detailed safety inform

    Full story
  • MasterControl Demonstrating Quality Management Software at MD&M East and DIA

    12 June, 2014 by Robyn Barnes, Marketing Communications, MasterControl Inc.

    June is the month for weddings and trade shows. Though we're not celebrating any nuptials, you’ll find MasterControl at MD&M East this week and at DIA the week of June 15.

    Full story
  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

    Full story
  • Leverage TOQ for a Faster, Cost-Effective Software Validation

    10 April, 2014 by Richard Dirkson, Senior Validation Services Consultant, MasterControl Inc.

    More and more regulated companies are using electronic quality management systems, but the concept of software validation remains a mystery to many engineers and quality professionals. In this article, I will try to shed light on the underlying goal of software validation within the context of FDA guidelines and offer a practical strategy.

    Full story
  • MasterControl Again Named to Software Magazine’s 31st Annual Software 500

    8 October, 2013 by Software Magazine

    MasterControl Inc. recently announced its inclusion in Software Magazine’s Software 500 ranking of the world’s largest software and service providers, now in its 31st year. This is the fifth year the company achieved this recognition.

    Full story