Navigating the evolving landscape of FDA 510(k) compliance is crucial for medical device manufacturers. This article explores the challenges and opportunities presented by recent scrutiny and proposed modernization of the 510(k) process. Discover how industry leaders can adapt their strategies, embrace global compliance standards, and leverage technology to ensure both innovation and patient safety in an ever-changing regulatory environment. Learn to navigate the "twilight zone" of predicate devices and position your company for success.
Discover how to streamline your medical device commercialization process in our comprehensive guide. Learn key steps for optimizing cross-functional teamwork, quality assurance, and regulatory compliance using modern digital tools. Enhance efficiency, ensure compliance, and bring your innovations to market faster. Read more for valuable insights.
Discover how digital transformation is revolutionizing life sciences manufacturing. Learn from MasterControl experts about implementing connected QMS, overcoming integration challenges, and achieving remarkable ROI through paperless processes. Gain insights from real-world success stories and explore strategies for building a connected quality and manufacturing ecosystem. Don't miss this essential guide to future-proofing your operations.
December 3, 2024
by Melissa Leygan, Owner, eQMS Consulting LLC
What happens when one quality management process interferes with the best practices of another? Learn strategies from eQMS Consulting’s Melissa Leygan on evaluating conflicting practices, improving current processes, and achieving smarter optimizations.
November 26, 2024
By Leah Jones, CEO, QA Connect Management Consulting, LLC
Audits are valuable tools for evaluating a medical device company’s performance and ongoing conformance to regulatory guidelines. They promote continuous process improvement in the medical device industry and help companies avoid recalls. Learn the benefits of an effective audit program and strategies for improving the effectiveness of your organization’s auditing function.
November 21, 2024
by David Orr, CEO, Medpoint, LLC
When manufacturing medical devices or pharmaceuticals, ensuring the proper functioning and reliability of equipment, systems, and processes is crucial for producing quality health care products. And every aspect of production hinges on proper validation. This blog post takes a dive deep into the three essential components of validation – IQ, OQ, and PQ – and the significance of validation in life sciences manufacturing settings.
November 20, 2024
by John Spanomanolis, Senior Principal QA Bio Medical Engineer Consultant, Foton Consulting
Three key technologies are forging the future of medical device risk management. This blog post examines how risk management is changing in the medical device industry and the bright future that the three complementary elements are creating.
November 13, 2024
by Mohit Jumani, Managing Consultant, Enterey Life Sciences Consulting
Products, people, processes, premises, and performance function together to create a safe, compliant cGMP manufacturing operation that delivers reliable products. Find out why an organization-spanning focus on these 5 Ps is the key to compliance in today’s fast-moving and highly regulated pharma environments.
Discover how integrating QMS and MES revolutionizes life science contract manufacturing. Learn about key challenges, real-world success, and how MasterControl's innovative, user-friendly platform delivers ROI while ensuring quality, compliance, and operational excellence in the competitive CMO landscape.
November 5, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Even the slightest quality failures can lead to product recalls. Keep your guard up against recalls by learning about their primary causes, how the FDA classifies them, the four critical steps of recall response, and smart approaches that can help you avoid them altogether.
With a 115% increase in FDA recalls since 2018, it's clear that life sciences companies need to take proactive measures to protect their products, reputation, and bottom line. This blog post explores the causes of recalls, their impact on consumers and businesses, and how connected digital solutions can help you prevent them.
Selecting the right hardware to support QMS and MES software solutions is a critical step life sciences manufacturers often overlook. Since it’s easy to be overwhelmed by the variety of hardware options available, DTG CEO Stephen Shaheen examines how to simplify those choices using a targeted and systematic approach.
October 23, 2024
By Lars Mouritsen, President & CEO, Avendium, LLC
Nervous about changes to the regulation of laboratory-developed tests (LDTs)? This blog post provides an in-depth analysis of the FDA’s final rule, outlines the history and context of LDT regulation, and highlights the phases of implementation, challenges, and opportunities for laboratories and manufacturers.
October 15, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
When FDA investigators identify issues that could potentially lead to product recalls, they typically stem from quality failures like inadequate documentation, poor quality event management, and insufficient process validation. Find out how you can effectively address these vulnerabilities and significantly reduce the risk of an FDA recall.
October 9, 2024
by Nathan Clark, Founder & CEO, Ganymede
This blog post shares some of the challenges, opportunities, and best practices for building a robust data platform that will enable AI in a way that supports GxP compliance. Discover why it comes down to data availability and infrastructure to ensure that your models are reliable, secure, and easily accessible for regulatory scrutiny.
October 3, 2024
by Philip Jarvis, Director of CQV and Digital Validation Strategy, VEQTOR and Peter Gordon, Digital Innovation and Technology Lead, VEQTOR
All the buzz around AI has life sciences companies wondering how emerging technologies can be applied to advance validation processes and improve quality management. VEQTOR’s team examines ways generative AI can be put to work to make real-time verification and seamless integration with digital ecosystems possible.
October 2, 2024
By Christina Pecoraro, Owner/Founder, Lotus Business Solutions LLC
The relationship between quality and sales team is not only crucial, but it can transform a company and drive unprecedented successes. Lotus Business Solutions’ Christina Pecoraro examines how this relationship can result in more positive customer experiences and company growth.
October 1, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
With FDA product recalls on the rise, life sciences companies need help navigating the intricacies of regulatory compliance and quality management. This blog post provides recommendations to help manufacturing and quality professionals effectively manage product quality issues, avoid receiving FDA Form 483 observations, and proactively prevent recalls.
Navigating ICH guidelines presents significant challenges for pharmaceutical manufacturers. This blog post explores the key difficulties in interpreting guidelines, adapting existing systems, and ensuring consistent application across departments. It offers practical solutions, emphasizing the role of modern pharma QMS software in overcoming these hurdles. Discover how leveraging technology can streamline compliance efforts, drive operational efficiency, and improve product quality.
September 24, 2024
By Dan Petkanas, Global Alliances Director, Elemental Machines
As quality and compliance standards in pharma become higher and stricter, the shift from error-prone manual processes to operationally robust, fully digitalized processes can no longer be considered optional. Elemental Machines’ Dan Petkanas explains why it’s critical for pharma manufacturers to embrace digital maturity.
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