GxP Lifeline

Advancing the Case for Quality in Medical Device Manufacturing

18 October, 2018 by Stephanie Christopher, Program Director, Medical Device Innovation Consortium

We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.
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Med Device Company Takes Flight With Life-Changing Innovation

3 October, 2018 by David Jensen, Staff Writer, MasterControl

Startup ventures are the embodiment of innovation – often hitting the ground running with little more than an idea and a vision. Part one of this three-part series introduces startup medical device company, BraveHeart Wearable Life Sensors, and how it is uniquely inspired by aviation.
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Top 5 Nutraceutical Trends in 2018 - Exploring Different Delivery Methods

4 October, 2018 by Sarah Beale, Staff Writer, MasterControl

The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.
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Airplane Preflight Check Exemplifies Quality in Med Device Design

10 October, 2018 by David Jensen, Staff Writer, MasterControl

Before any aircraft leaves the ground, it undergoes a preflight check. Part 2 of this series on BraveHeart features Steve McCalmont performing an aircraft preflight check to illustrate how this critical part of flying equates to the importance of incorporating quality in the design of a medical device.
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Expert Tips on Enhancing CAPA Through Innovation

2 October, 2018 by James Jardine, Staff Writer, MasterControl

This examination of quality guru Ken Peterson’s proven corrective and preventive action (CAPA) innovation techniques provides strategies and sequential principles for refining transformative CAPA innovations, avoiding half-baked solutions and obtaining organizational buy-in of revolutionary quality event management ideas.
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How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry

26 September, 2018 by David Jensen, Staff Writer, MasterControl

The countdown to the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) deadlines is underway. However, transition issues are creating a logistical logjam for both the medical device industry and the European Commission (EC), which is impacting the med device industry. MedTech Europe still wants the EC to stop the clock.
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Getting Paid: A Shifting Medical Device Reimbursement Landscape in Australia

9 October, 2018 by Sarah Griffin, Principal Consultant, Brandwood Biomedical (Australia)

Australia is increasingly an attractive market for medical device manufacturers. But medtech companies need to know the complexities of the country’s blended public and private hospital systems to avoid confusion and fully profit from its device reimbursement opportunities.
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New Digital Pathways Boost Success Rate of Med Device Introductions

25 September, 2018 by David Jensen, Staff Writer, MasterControl

Launching a med device always has a sense of urgency. However, failing to gain market approval or facing a recall can be costly. You avoid these scenarios with new digital pathways that facilitate faster and more efficient regulatory information management (RIM) and product life cycle development.
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FMEA Without Tears: A Prescription to Reduce Pain and Confusion

11 October, 2018 by Rai Chowdhary, CEO and Founder, The KPI System

Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.
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10 Key Steps for Implementing a QMS

27 September, 2018 by Tifany Desprez, Communication & Marketing Manager with MasterControl Partner Apsalys

Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.
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The Evolution of Medical Device Clinical Trials, Part 2

20 September, 2018 by James Jardine, Staff Writer, MasterControl

Regulatory shifts and global advancements are reshaping the way medical device companies approach their clinical trials. Learn about the present state of medical device regulatory compliance and envision the future of the clinical landscape for devices.
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The Evolution of Medical Device Clinical Trials, Part 1

19 September, 2018 by James Jardine, Staff Writer, MasterControl

Medical devices face a unique set of challenges during the course of clinical trials. Get an insightful look into the regulatory standards that affect medical device clinical trials and learn how clinical trials for devices are significantly different from – and often more flexible than – those of drug products.
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The Globalization of Clinical Data in Medtech

18 September, 2018 by Danielle Giroud, Founder and CEO, MD-Clinicals (Switzerland)

Regulatory agencies are increasingly demanding prospective clinical data as part of the clinical evidence for medical device market access. That is increasing the costs borne by manufacturers. The silver lining: the acceptance of foreign data by those agencies, including China, is also on the rise.
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How to Approach Design Control From Both FDA and ISO Viewpoints

13 September, 2018 by Mike Rigert, Staff Writer, MasterControl

Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.
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Leveraging the Value of Quality in Your Business Through ISO

11 September, 2018 by Christine Park, Founder and Owner, Christine Park and Associates

Rather than viewing ISO as a burden, think of it as a standard upon which you can build a foundation for the sustainability and growth of your business. Learn how to use ISO as a catalyst to align a quality management system (QMS) with the strategic direction of your company.
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Top 5 Nutraceutical Trends in 2018 – Functional Foods

30 August, 2018 by Sarah Beale, Staff Writer, MasterControl

The dietary supplement and functional foods markets overlap to a certain extent. Rather than trying to resist this, nutraceutical companies can get the best of both worlds by expanding their offerings to include functional snacks and beverages.
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Ugly Babies, Silent Enemies and Other Short Stories from a Continuous Improvement Conference

6 September, 2018 by Chet Marchwinski, Communications Director, Lean Enterprise Institute

Continuous improvement professionals, managers, and executives from the U.S. and Canada presented at the recent Canadian Lean Conference in June 2018, which drew about 1,000 business leaders to Winnipeg. Presenters shared lessons and results from lean transformation efforts as well as some personal journeys. Here’s a digest of some of the stories I heard.
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Avoiding the Top 5 Violations of 21 CFR Part 111

23 August, 2018 by Sarah Beale, Staff Writer, MasterControl

All dietary supplement companies must comply with the CGMPs outlined in 21 CFR Part 111. However, doing this and recording it is easier said than done. The top 5 violations recorded by the FDA show which areas need the most improvement and how automated systems can help
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Keeping Up With Regulatory Changes for Medical Devices

4 September, 2018 by Michelle Lott, Principal and Founder, Lean RAQA

Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.
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Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2

15 August, 2018 by Carla Frances Reed, President, New Creed

A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.
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