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Software & IT
How Medical Device Quality Teams Can Navigate Digital Transformation
The potential benefits from digitalization extend beyond increased productivity for medical device manufacturing.Online Exclusives Stephen McCarthy, VP of Digital Innovation, Sparta Systems 10.18.18
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Software & IT
How to Choose the Right Quality Management System
Beyond the requirement for medical device companies, having a quality management system (QMS) provides a framework to deliver consistency and efficiency in a business. The two main regulations requiring a QMS are FDA 21 CFR 820 (U.S.) and ISO 13485 (…Chuck Cimalore and Rasean Hamilton, Omnify Software and EarLens 09.07.18
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Digital Health
The Future of Artificial Intelligence and Quality Management
Industry leaders are required to keep up with change. In regulated industries like the life sciences, ensuring the safety of all products—and therefore, the public—is a main priority. Change is the necessary component driving continuous i…Emily Ysaguirre, Content Marketing Writer, EtQ 10.05.17
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Software & IT
Quality Nightmares #25
Quality Nightmares offers a humorous look at the challenges faced by medtech professionals.MasterControl 08.22.17
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Software & IT | Testing
How an Automated Quality Management System Eases Compliance with ISO 13485:2016
Change is good, but nobody said it was easy. Clichés aside, adjusting to a change in standards may be a challenge, although it is ultimately worth the time and effort put in. ISO 13485:2016, the newest ISO revision for medical devices, contain…Alexa Sussman , EtQ 09.08.16
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Contract Manufacturing | Materials | Software & IT
A Holistic Approach to Quality and Supplier Management
Those who outsource to fulfill manufacturing needs already know that suppliers are an integral part of a company’s operations. In fact, the relationships with suppliers might be some of the most influential a company will make. So how does one…Alexa Sussman, EtQ 07.20.16
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Materials | R&D & Design | Software & IT
How Automation Ensures Improvement: Change Management in Quality Management Systems
Change is common within the life sciences industry, where a product may be designed only once but change occurs often throughout the product lifecycle. An organization’s ability to incorporate quality into every aspect of a change results in ov…Brenda Percy, EtQ Inc. 04.06.16
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Materials | R&D & Design | Software & IT | Testing
Change for the Better: Change Management and Quality Management
Change for the Better: Change Management and Quality ManagementBrenda Percy 06.08.09
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Materials | R&D & Design | Software & IT
Quality Perspectives: Integrating Change and Quality Management
Integrating change and quality management.Brenda Percy 03.04.09
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Materials | R&D & Design | Software & IT
Quality Perspectives: Change and Quality Management are Necessities for Businesses
Change and quality management are necessities for businesses.Brenda Percy 02.04.09
