GxP Lifeline

Showing items tagged as Medical Device

  • Top 10 most important capabilities an EQMS solution should have for medical device companies

    Medical Device Industry Guide to Selecting QMS Software

    If your medical device company is planning to implement quality management system software, you can’t afford to overlook the 10 most important capabilities an EQMS solution should have. Get the facts about EQMS software before you invest.

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    FDA Details Post-COVID Transition Guidelines for EUA Devices

    In February 2020, the FDA granted emergency use authorization (EUA) to certain medical devices needed to address the challenges imposed by the COVID-19 virus. The agency recently drafted two new guidances to make preparations for med device companies to return to normal regulatory operations.

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  • 3 Tips for Effective Risk Analysis in the Medical Device Industry featured by MasterControl

    3 Tips for Effective Risk Analysis in the Medical Device Industry

    Medical device manufacturers need to manage risk from the beginning of product design and continue throughout the full product lifecycle - anything less jeopardizes product quality. Connected risk analysis is essential because it gives you a holistic view of risks and their potential impact. Having this level of visibility requires a digital quality management system.

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  • How Northeast Scientific leverages MasterControl’s Medical Device Manufacturing execution software.

    Vision and Paperless Ops Make Northeast Scientific a MedTech Industry Leader

    Many medical device manufacturing businesses are busily exploring ways to reduce the soaring costs of health care. Medical device remanufacturer Northeast Scientific is contributing to the effort by repurposing single-use devices (SUDs) to make them fit and safe to reuse.

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  • MasterControl’s Medical device QMS can help comply with medical device quality regulations.

    4 Ways to Prepare for UK Medical Device Regulations

    The United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) recently issued new guidance pertaining to regulated medical devices in the UK. Here’s how to prepare.

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  • Supply chain best practices for the medical device industry

    Medical Device Supply Chain Backup

    It pays to have backup plans, and the supply chain is no different. Constantly fluctuating COVID-19 protocols and transportation issues continue to plague the medical device industry, but there are steps that can be taken to deal with these problems.

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  • Medical Device Manufacturing Digitization Trends and Best Practices with MasterControl Manufacturing Software

    Medical Device Manufacturing Trends, Part 1: Resilient Supply Chains Require Modern Tools

    While visibility, agility, and responsiveness have been priorities in managing supply chains for decades, the disruption and volatility around the COVID-19 pandemic amplified their critical role. In doing so, it brought to light the need to digitize and integrate supply chain systems to ensure all relevant data and insights can be connected for optimal resiliency. To protect themselves in the face of supply chain volatility, medical device manufacturers should reassess their supply chain capabilities with an eye toward proactive, tech-enabled solutions.

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  • Medical Device Manufacturing Digital Solution

    Attain the Manufacturing Trifecta: Decrease Expenses, Increase Efficiency, and Accelerate Product Release

    A medical device manufacturer was working across two disparate systems. The result? Mistakes made their way into the manufacturing process, which resulted in lengthy review times, and delayed speed to market. The solution was digitization, and it immediately saved them $42,000 per year.

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  • GxP Lifeline, a blog by MasterControl: image of hands scrolling on a tablet with a city background

    Not-To-Be Missed Blog Posts From 2021

    Before 2021 is gone, catch up on our most informative blogs that will help you conquer the challenges you’ll face next year.

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  • 2021-bl-med-device-quality-trends_132x132

    Small Regulatory Steps for AI in SaMD

    Artificial intelligence (AI) in health care has enormous potential, but AI-enabled software as a medical device (SaMD) is charting new territory. Last year, regulators indicated some of their priorities for AI in SaMD and what regulations might look like in the future.

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    Regulatory Records Primer: Decoding the Requirements for Medical Device Manufacturers

    The U.S. Food and Drug Administration (FDA) set up the Quality System Regulation (QSR) to give medical device companies guidelines for ensuring quality, safety, and efficacy of their devices. There are many components to the QSR, but this post focuses on the requirements that apply to records.

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  • 2021-bl-iso-9001_132x132

    5 Tips for a Successful ISO 9001:2015 Certification Audit

    ISO 9001 defines the criteria for quality management systems (QMS), which mostly applies to companies involved with regulated products or services. This post provides useful tips for successfully preparing for and completing an ISO 9001:2015 audit.

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  • 2021-bl-cyber-security-risk-management_132x132

    Cybersecurity in Medical Device Development

    The vast interconnectivity of medical devices is widening the attack surface of the public health sector. Intrusions and breaches are possible because of weaknesses in a medical device’s cybersecurity design. This post discusses the security vulnerabilities in medical devices and provides tips and resources for companies to strengthen their cybersecurity posture.

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  • 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-med-device-trends_132x132

    Digitization in Medical Device Manufacturing: 4 Priorities

    Though most manufacturers may recognize the benefits of digital transformation, many don’t see the roadmap. But there is a realistic path forward that helps mitigate or minimize many real barriers. The key is to make small changes in areas where you will see the biggest impact.

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  • 2021-bl-metrics-collection_132x132

    5 Steps to Metrics Collection and Usage

    Gut instinct doesn’t cut it when making business decisions — especially in businesses that revolve around compliance and consumer safety. Hence the emphasis on big data and making data-driven decisions. It’s easy to say you want to use data, but to use it effectively you first need to take a step back and look at the bigger picture.

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  • 2021-bl-cfr-part-11_132x132

    20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.

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  • 2021-bl-evolution-med-device_132x132

    The Evolution of Medical Device Clinical Trials: Adapting to Regulatory Changes

    Regulatory shifts and the ever-accelerating pace of innovation are necessitating a new approach to clinical investigations of medical devices. Learn about the unique regulatory pathways that devices traverse and why recent updates to compliance standards are calling for risk-based clinical strategies.

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  • 2021-bl-explain-your-quality_132x132

    How to Explain Your Quality Job to Young Kids in 4 Steps

    When it was time to celebrate Career Day at my daughter’s school, she begged me to come talk to her first-grade class. I dreaded it. How do you explain to 6- and 7-year-olds what a quality manager does?

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  • 2021-bl-audit-checklists_132x132

    Understanding Auditor Checklists to Help Prepare for Audits and Inspections

    A checklist can be a simple yet powerful tool that you use to stay focused and complete essential tasks quickly and efficiently. As an auditor’s tool, a checklist can help ensure a well-planned, systematic, and consistent approach to audits. If the best way for an organization to survive an audit is to always be ready for one, you will be better prepared if you have an idea of what questions an auditor would ask.

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