3 ways to streamline global medical device registrations

Global medical device registrations can be time-consuming and costly for organizations. Here are some ways to make the process better. Alex Butler, MasterControl Obtaining clearance or approval for a medical device in the U.S. is cause for celebration. Obtaining clearance or approval for a medical device in multiple foreign countries is cause for jubilation. On

MD&M West: 10 technologies you should know

MD&M West is one of the largest medical device manufacturing events in the world, so it’s easy to get lost on the show floor. Even if you were in Anaheim, Calif., for the event last week, you may have missed a lot. From a new robotics insights display from Rethink Robotics to a disinfectant-resistant plastic

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MasterControl thinks it can speed up validation: Here’s how

MasterControl officials are touting cloud-based software-as-a-service as a way for medical device manufacturers to speed up validation processes. Their first validation excellence tool (VxT) involves risk-based software validation. The VxT — which MasterControl (Salt Lake City) showed off last week at MD&M West in Anaheim, Calif. — is a value-add on top of MasterCloud’s software solutions.

MasterControl and Lorenz: Here’s how they’ve streamlined document management

MasterControl, a provider of enterprise quality management systems, and Lorenz Life Sciences Group, a regulatory information management solutions provider, have a decade of joint success when it comes to customers streamlining and integrating their document and submission management services. “Integrating with an industry leader, MasterControl, has been providing a seamless way for customers to drag-and-drop

MasterControl reports innovation and continued growth

MasterControl, a leading global provider of enterprise quality management systems (EQMS) and quality and compliance consulting services, says it has experienced a stellar year in terms of company growth and customer success and delivering new advancements to the market. “If I had to categorize the scope of 2016 for MasterControl, I would call it a

MasterControl provides FDA Readiness Toolkit

The guidelines set forth by the FDA are a major factor in ensuring that companies manufacture and sell products that are safe, reliable, and effective. But many manufacturers are so bogged down with inefficient practices that their quality systems are unreliable and out of compliance. MasterControl’s FDA Readiness Toolkit is designed to get manufacturers up

What does the FDA say about validating software?

Kevin Ballard/Director of Software Validation/MasterControl Software validation is required by law for companies that operate under the purview of the FDA and EMA. Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and 21

MasterControl: Top 7 Takeaways from AdvaMed 2016

by Lisa Weeks, Marketing Communications Specialist, MasterControl Last week, I attended AdvaMed 2016, the leading medtech conference in North America. This year’s conference was the biggest yet, with more than 2,650 medtech professionals descending on Minneapolis for three days (October 17-19) of educational sessions, lively panel discussions and inspiring patient stories. As the birthplace of

Speeding up software validation

The process of software validation is fraught with long lead times, redundancy and expense. The tools most commonly used are good ones, but by making better use of technology they could be improved – at least according to Kevin Ballard, director of software validation at MasterControl. But let’s back up a bit. To start, software regulation

MasterControl launches industry’s first transfer performance qualification solution

MasterControl has again set an industry benchmark by being the first company to deliver a Transfer Performance Qualification (TPQ) solution, which automates a previously cumbersome portion of the software validation process—a requirement for highly regulated companies. Software validation establishes documented evidence that demonstrates an organization has a high degree of assurance that the software it

ARC Experts and MasterControl exec talks mobile health innovation

Walt Murray, ICLA, CSSMBB, is the CEO of ARC Experts and a strategic partner for MasterControl Quality & Compliance Consulting who recently gave a presentation on “Identifying and Conquering Your Design Control Risks Specific to Your Mobile Health Innovation” at MD&M East. His presentation highlighted design and development, along with best practices. Walt joins us

The first step to navigating your combination product’s regulatory pathway: PMOA

Editor’s Note: This article is written by Winston Brown, VP of Global Quality & Regulatory Affairs at Phillips-Medisize. The drug-device combination product market is growing at a rapid pace. By 2019, it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66

MasterControl to demo industry’s first CQMS software at DIA 2016

MasterControl (DIA Booth #1103), a leading global provider of enterprise quality management software and quality consulting services for regulated businesses, will be demonstrating the industry’s first Clinical Quality Management System (CQMS) at the DIA 2016 52nd Annual Meeting June 26-30, 2016. MasterControl’s Patricia Santos-Serrao, RAC, Director of Clinical and Regulatory Solutions for the Pharmaceutical Industry,

MasterControl unveils v11.5 with unique user interface

MasterControl, a global provider of Enterprise Quality Management Software (EQMS) and consulting services for regulated businesses, now offers a new version of its software suite. MasterControl v11.5 is the first major release to focus entirely on the user experience (UX). MasterControl call the UX its “Beautiful User Experience” initiative. This approach to delivering exceptional experiences

UL training courses now available from MasterControl

UL EduNeering courses, the global gold standard for Quality & Compliance eLearning programs, are now available directly from MasterControl, a leading global provider of electronic quality management systems (EQMS) and quality consulting services. The SCORM-compliant Quality & Compliance Essentials courses, available via the MasterControl Training module, are sets of self-paced eLearning courses that are targeted