GxP Lifeline

 

  • FDA’s Plan to Replace QSR With ISO 13485: Pros and Cons

    29 May, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.

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  • 2019 Med Device Trends to Watch For: Regulatory Changes

    14 February, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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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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  • Regulatory Barriers to Innovation for Startups

    31 July, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • Risk-Based Approach as Clear as Mud

    16 January, 2018 by Michelle Lott, Principal and Founder, Lean RAQA Systems

    This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.

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  • Understanding the Use of “Where Appropriate/As Appropriate” Within the ISO 13485:2016 Standard

    12 September, 2017 by Christine Park, Consultant, Christine Park & Associates

    Historically, the term “where appropriate” and/or “as appropriate” have been implied within the ISO 13485 standards as well as the FDA 21 CFR 820 Quality System Regulations. The FDA has always explained that “as appropriate” means it is appropriate unless you can justify why it isn’t appropriate.

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  • ISO 13485:2016 What are the Changes About?

    3 March, 2016 Linda Chatwin, Esq, RAC Manager Medical Regulatory Advisory Services, North America UL LLC

    ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.

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  • Can’t-Miss Tips for Exposing Risk during Medical Device Development

    7 April, 2016 Lisa Weeks, MasterControl Communications

    Do you confuse risk analysis with risk assessment? Do you struggle to distinguish between a hazard and harm? Does the term risk management strike fear into your heart? If so, you’re not alone. Despite the publication of ISO 14971 in 2000 and, more recently, the inclusion of risk-based thinking among ISO 9001:2015 and ISO 13485:2016 requirements, many device manufacturers still struggle to understand, identify, assess and track risk across the product development lifecycle.

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  • The Importance of Applying Risk-based Design Control to Process Validation

    18 April, 2016 Lisa Weeks, MasterControl Communications

    In order to have a successful submission for approval of drugs, medical device, biotechnology, supplements, combination product and IVD an organization must have a prolific and structured design process. According to regulators, this process must now include the explicit condition of technical transfer as a formal review step to manufacturing/assembly.

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  • What, No Internal Audits?

    21 June, 2016 Dr. Christopher Joseph Devine, President Devine Guidance International

    For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.

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  • Aligning ISO 13485:2016 With Additional Standards and Regulations

    13 July, 2016 Marci Crane, Localization Manager, MasterControl

    MedTech Intelligence, a content hub for the medical device industry, provides a continuous stream of new business analysis, technological news, trend summaries, regulations, expert opinions and networking opportunities to medical device professionals. MedTech Intelligence will host the upcoming 13485:2016 conference on July 28-29, 2016 at Dentons, 1900 K Street NW, Washington D.C.

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  • Top 5 Medical Device Trends of 2016

    26 May, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Ben Franklin said, “When you’re finished changing, you’re finished.” That’s advice medical device makers can take to heart because 2016 really is shaping up to be a year of unprecedented industry change. Non-traditional medical device companies, such as Google and Apple, are entering the space, disrupting the business models of major industry players.

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  • Your Top 10 Questions About ISO 13485:2016—Answered!

    2 February, 2017 by Lisa Weeks, Staff Writer, MasterControl

    In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise

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  • 2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

    2 March, 2017 Marci Crane, Staff Writer, MasterControl

    For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of

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