Showing items tagged as Medical Device Regulation (MDR)

  • Planning Ahead for Transition to the EU's MDR: A How-To Guide, Part 2

    20 November, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    Preparing for the transition to the European Union’s Medical Device Regulation (MDR) requirements is proving more formidable than some medical device manufacturers originally anticipated. This is part 2 of blog series about what kind of challenges medtech companies are experiencing and how you can create a workable transition plan.

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  • Planning Ahead for Transition to the EU’s MDR: A How-To Guide, Part 1

    19 November, 2018 by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health

    Medical device manufacturers are finding it more difficult than initially anticipated to prepare for the European Union’s (EU) Medical Device Regulation (MDR) transition period, which ends May 2020. Find out what kind of challenges medtech companies are experiencing and how you can create a workable transition plan in this two-part blog series.

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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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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 2018 by James Jardine, Staff Writer, MasterControl

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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  • Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

    3 July, 2018 by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting

    Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

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  • Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

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

    Australasia is quickly becoming a hotbed for life sector manufacturers including pharmaceutial and medical device companies from around the globe seeking regulatory approval for their products and other opportunities. Find out why.

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  • TGA Process for Conformity Assessment in Australia

    7 June, 2018 by Grant Bennett, Senior Consultant and CEO, Brandwood Biomedical

    If you’re considering the Australian market for your medical device product and don’t have CE marking, the conformity assessment is an ever-increasing opportunity to enter the market. Furthermore, with the ever-changing landscape in Europe, many would suggest that Australia's Therapeutic Good Administration (TGA) is a well-established and understood pathway, whereas the European market is becoming somewhat more challenging and less understood.

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  • Top 5 Trends That Will Shape the Medical Device Industry in 2018

    12 April, 2018 by David Jensen, Staff Writer, MasterControl

    At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.

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  • New European Med Device Regulation: 2020 Looms Large for Medtech Firms

    15 February, 2018 by Cindy Fazzi, Staff Writer, MasterControl

    In 2020, the United States will hold a presidential election. Tokyo will host the Summer Olympics. For the medtech industry, the European Union’s Medical Device Regulation (MDR) will take effect. Politicians and athletes have been gearing up for 2020 and so should medical device firms.

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  • FY2018 Increasing User Fees Affects Submission Strategy

    11 October, 2017 by Michelle Lott, Founder, Lean RAQA Systems, LLC

    Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

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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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  • Understanding FDA’s UDI Guidance: The Key to Compliance

    13 June, 2017 by Beth Pedersen, Staff Writer, MasterControl

    The latter half of 2016 saw the second highest number of U.S. medical device recalls since 2000 with 650 medical devices and over 180 million units pulled from the market, according to Stericycle ExpertSOLUTIONS’

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