Search Results for 'quality'

Software & IT

Connected Quality Systems Reduce Risks

For the best outcome in medical design innovation with highly outsourced teams, having a rock-solid approach to quality is a prerequisite. As regulatory standards, market requirements, and device complexities have evolved, so too has the weight of th…

Scott Reedy, Senior Director of Marketing, Arena Solutions 06.13.19
Software & IT

Quality Systems: It’s All Greek to Us

I admire people who love what they do. There’s a lot of truth to the oft-quoted Mark Twain observation: “Find a job you enjoy doing, and you will never have to work a day in your life.” For the most part, that applies to me. But…

Dawn A. Lissy, President & Founder, Empirical 04.03.19
Software & IT

Hand-in-Hand with Quality and (Regulatory) Changes

Greenlight Guru’s founder speaks with MPO about the firm’s FDA-connected initiatives and the changing regulatory landscape.

Online Exclusives Sean Fenske, Editor-in-Chief 04.03.19
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
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
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
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
Contract Manufacturing | Materials | R&D & Design | Software & IT | Testing

Quality with a Capital Q

With OEMs consolidating supplier lists as a means of managing regulatory requirements, "better" must trump "less costly" in the process.

Jim Stommen , Contributing Writer 05.10.12
Materials | R&D & Design | Software & IT | Testing

Change for the Better: Change Management and Quality Management

Change for the Better: Change Management and Quality Management

Brenda Percy 06.08.09
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