Showing items tagged as Regulations

  • 2021-bl-med-device-managing-risk_132x132

    5 Medical Device Best Practices for Managing Risk to Users, Patients, and the Environment

    Medical device companies can take a risk-based approach, which simplifies regulatory compliance while alleviating concerns about speed-to-market and new device clearance overhead costs to maintain compliance.

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  • 2021-bl-standards-harmonization-and-eu-mdr_132x132

    The Standards Harmonization Process and 5 Tips to Manage It With EU MDR

    With the roll out of the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), an increasing number of harmonized standards are out of date. This post addresses the current status of harmonized standards under MDR/IVDR and provides tips for dealing with the challenges of meeting compliance with the new regulations.

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  • 2021-bl-qarad-eifu_132x132

    What do Notified Bodies expect of your eIFU solution and its implementation?

    It is often crucial for safety that users have access to the correct instructions for use (IFU) when they need it. Therefore, it is logical that eIFU solutions are subject to strict requirements. Consequently, notified bodies (NB) will verify how a manufacturer has designed and implemented their eIFU solution in agreement with the requirements.

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  • 2021-bl-quality-assurance-quality-control_132x132

    Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

    Quality assurance and quality control aren’t identical or interchangeable. Comparing the two functions to television’s most enduring police crime drama might help you explain their differences to your peers.

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  • 2021-bl-analytics-trends-brief_132x132

    May the Data Be With You

    Using the Force to make decisions in Star Wars works well. Tragically, since most of us don’t have that ability in the real world, we’d probably be better served if we listened to C-3PO more. While we’re short on protocol droids, we do have the tools to let you make decisions using advanced analytics and artificial intelligence (AI). And the odds of those paying off are considerably better than navigating an asteroid field.

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  • 2020-bl-manufacturing-excellence-06_132x132

    GxP Training Redefined?

    To meet GxP training requirements, it’s important to understand the basics: what GxP means, how it relates to regulatory compliance, and how organizational change management can help you ensure your team receives adequate and consistent training.

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  • 2021-bl-transitioning-ivdr_132x132

    Challenges with Transitioning to the EU In Vitro Diagnostic Devices Regulation

    The deadline for the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) is about a year away, and if you haven’t started preparing, now is the time. Understand the challenges you might face during the process and what you can do to address them.

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  • 2021-bl-spectra-terms-explained-2_132x132

    Can I get a Translation Please? Tips to Ensuring Productive Communications with Regulatory Authorities, Part Two

    Understand simple strategies for communicating with your review team to ensure you’re speaking a language that your regulatory authority understands, and more importantly, a language that can get your product to market.

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  • 2020-bl-focusing-resources_132x132

    Trend Analysis: Making the Most of Meaningful Quality Data

    Trend analysis in quality management is particularly useful for monitoring process changes that can yield substantial process improvements. Learn how advanced digital tools can supercharge your trend analysis capabilities by providing access to real-time, connected quality data.

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  • 2020-bl-501k-guidance_132x132

    FDA’s New 510(k) Pathway Highlights Safety and Performance Data

    The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace. The agency set up a new 510(k) pathway for achieving market approval, which is device-specific and based on safety and performance data. In pursuing this pathway, the agency emphasizes the importance of continuous improvement and effective data management.

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  • mind-the-gap_132x132_Thumbnail

    Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

    If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.

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  • 2020-bl-thumb-adios-device-excise-tax

    Christmas Comes Early to Medtech: U.S. Repeals Device Excise Tax

    With the release of the ninth and final Star Wars film in the so-called Skywalker saga, December 2019 was a big month for fans. It was even a bigger month in the medtech galaxy, where the U.S. Congress’ permanent repeal of the 2.3% device excise tax extends a prime opportunity to device makers to reinvest the savings in cost-competitive measures.

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  • 2019-bl-thumb-to-pre-sub-or-not-to-pre-sub

    To Pre-Sub or Not to Pre-Sub? Weighing the Value of the FDA’s Pre-Submission Program

    The U.S. Food and Drug Administration’s Pre-Submission program was created to with the intent of lowering medical device companies’ submission times. Gain some valuable insights about how the program can help you get clearance for your device and increase speed to market.

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  • 2019-bl-thumb-prepare-for-the-future-of-quality-now

    5 Ways to Prepare for the Future of Quality Now

    The future of quality is closer than you might think, and the time to prepare is now. During the 2019 Masters Summit, MasterControl Partner KPMG presented a session on the future of quality and how it can help the life sciences industries now.

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  • 2019-bl-thumb-mdsap-world-of-opportunity-med-devices

    Why MDSAP Opens a World of Opportunity for Med Devices

    Global regulatory agencies are rallying to help drive the momentum for medical device innovation. The International Medical Device Regulators Forum (IMDRF) recently implemented a regulatory consortium called the Medical Device Single Audit Program (MDSAP). The program is designed to grant regulatory approval of medical devices in several global regions through a single audit. In this article, Luis Jimenez, vice president of business development at Brandwood CKC, discusses why this program is highly beneficial for medical device manufacturers.

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  • 2019-bl-thumb-fda-unveils-draft-guidance-on-asca

    The FDA Unveils Draft Guidance on ASCA for Device Conformity Assessment Testing

    The U.S. Food and Drug Administration (FDA) recently received draft guidance on its proposed pilot program, the Accreditation Scheme for Conformity Assessment (ASCA), for medical device premarket reviews. The intent of the pilot is to realize greater efficiencies and confidence in the testing and reviews process for all involved parties. Find out if ASCA might be viable for your organization.

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  • 2019-bl-thumb-brandwood-transition-from-mdd-to-mdr

    Q&A: Device Manufacturers’ FAQs on the EU’s Medical Device Regulation (MDR)

    Medical device manufacturers globally are grappling to recertify their devices against the European Union’s new Medical Device Regulation (MDR), which takes affect May 26, 2020. To help manufacturers make sense of the MDR, a Q&A was conducted with two medtech subject matter experts who tackle some of the most commonly asked questions about the MDR and how to approach it.

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  • 2019-bl-thumb-how-the-tga-regulates-drugs-and-devices

    Tips on How the TGA Regulates Drugs, Devices and Combination Products

    Global regulatory requirements are seemingly in a state of constant flux. Thus, it can be confusing for life sciences companies to grasp the exact nature of each region’s regulatory agency policies. This article breaks down some of the regulatory basics and more nuanced portions of Australia’s Therapeutic Goods Administration (TGA).

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  • 2019-bl-build-an-effective-global-regulatory-strategy-page-image

    Building an Effective Global Regulatory Strategy for Medical Devices

    As new technologies evolve, the device requirements for medical device companies in various global markets has become more complex and nuanced. To be successful in key markets around the world, device makers need to study these regulatory environments and develop a strategy to more seamlessly and efficiently acquire regulatory approvals.

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  • business-icons-digital-touchboard-132

    Regulatory Changes Top the List of 2019 Med Device Trends to Watch For

    If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way. The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.

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