Showing items tagged as Medical Device

  • ISO, Regulatory Requirement Changes Loom

    1 September, 2017 B. Christine Park, Consultant, Christine Park & Associates

    As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

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  • Good Communication Skills are Key for Inspection Readiness

    25 August, 2017 UL

    When an FDA inspector comes to your door, it is usually a time of stress and uncertainty.  You need to handle logistical elements like where the inspectors are going to be placed, how you 

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  • Avoiding CAPA Pitfalls: 10 Tips from a Food Industry Quality Expert

    22 August, 2017 by James Jardine, Staff Writer, MasterControl

    At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider

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  • Nuts and Bolts of 510(K) Submissions

    17 August, 2017 by Rob Packard President, Medical Device Academy, Inc.

    A 510(k) is pre-market notification of medical devices to the US FDA. The number “510” refers to section of the Food, Drug and Cosmetic Act. “k” is the subsection specific to pre-market notification. Details regulating the process, however, are found in 21 CFR §807.

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  • Regulatory Strategies for AI and Emerging Technologies

    14 August, 2017 by Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc. and Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.

    Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.

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  • 6 Opportunities and Challenges Combo Product Makers Should Be Aware of in 2017

    8 August, 2017 by Alex Butler, Manager Medical Device Solutions, MasterControl

    Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that merge two or more different types of regulated drugs, medical devices or biologics into one multi-faceted treatment. As more device and pharma companies join forces to develop combo products, the traditional industry and regulatory boundary lines between the two sectors become blurred, presenting medical product makers

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  • Is the 510(k) Process as Worthless as the Federal Courts Seem to Believe?

    3 August, 2017 by Jeffrey K. Shapiro, Director, Hyman, Phelps, McNamara, P.C.

    Does the Food and Drug Administration’s review of medical devices in the 510(k) program involve a substantial review of safety and effectiveness? FDA says 

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  • UDI as Med Device Product Tracking Software (Why That’s a Good Thing)

    1 August, 2017 Cindy Fazzi, Staff Writer, MasterControl

    When the U.S. Food and Drug Administration (FDA) mandated the use of unique device identification or identifier (UDI), some people voiced concerns over the high cost of the requirement, as well as the technology challenges it posed. What is UDI and why is it important?

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  • Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials

    25 July, 2017 by Jamie Arnott, Project Director and Caitlin Hirschman, Clinical Team Lead, Rho

    When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. From study design to logistics to recruitment, there are real differences between studies conducted in pediatric populations and studies conducted in adult populations.

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  • 5 Trends Driving Disruption in the Med Device Industry in 2017

    20 July, 2017 Lisa Weeks, Staff Writer, MasterControl

    The medical device industry is complex, ever-changing and highly regulated, that much we know. We also know that, despite the complexity, the outlook is rosy for device manufacturers that can recognize—and navigate—the major trends of the day. The purpose of this post is twofold: to identify the trends that are likely to have significant impact on the industry this year, and to provide some high-level tips for exploiting them.

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  • How Training Personnel on Your Quality System Can Produce Positive ROI. Don’t Stop at the Quality Manager.

    18 July, 2017 Greg Peckford, Founder, Quality Career Advancement

    Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their quality program, and to ensure it is effective, is to train as many people as possible or even all employees, depending on the size of the company, on the concepts and strategies that its quality management system is based on.

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  • FDA Favors Collaborative Approach to Medical Device Cybersecurity

    13 July, 2017 by David Jensen, Staff Writer, MasterControl

    Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the subject at MedTech Intelligence’s conference on Medical Device Cybersecurity.

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  • Developing a Quality System on a Managed Budget

    11 July, 2017 by Keith Matthews, Director Quality Systems, Regulatory Compliance Associates Inc.

    Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction.  Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving.  Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy. 

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  • Why the Supply Chain Is so Important Toward Supporting Business Success

    6 July, 2017 by Bob Ferrari, Managing Director, The Ferrari Consulting and Research Group, Founder and Executive Editor, Supply Chain Matters blog

    I term myself as an observer of multi-industry supply chains from respective management practitioner, technology implementer and industry analyst roles. I founded the

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  • An Exciting Time in Life Sciences: Touching Stories from a Life-Improving Industry

    29 June, 2017 by Marci Crane, Staff Writer, MasterControl

    A recent industry outlook for the life sciences industry published by Deloitte mentions opportunities and concerns facing the life sciences industry.

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  • Combination Products and CGMPs: What You Should Know

    27 June, 2017 Dr. Karl M. Kapp, Department of Instructional Technology, Bloomsburg University

     At the beginning of this year, the FDA    issued final guidance for Current Good  Manufacturing Practice (CGMPs)  Requirements for Combination Products.  This guidance is for therapeutic and  diagnostic products that combine drugs,  devices, and/or biological products. This  guidance has become increasingly  necessary due to the rapid pace of technological advances in the life science industry where product types continue to merge and blur lines

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  • Free Webinar: What the New European Med Device Regulation Means

    22 June, 2017 by Cindy Fazzi, Staff Writer, MasterControl

    The European Parliament recently adopted a stricter, more extensive Medical Device Regulation (MDR) to replace the Medical Device Directives (MDD). It will affect all manufacturers selling devices in the European Union. What does the new regulation mean for device manufacturers? Will it make life harder and increase costs for them?

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  • Training Does Not Stand Alone: The Quest for Training Effectiveness Continues

    8 June, 2017 by Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.

    While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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