Showing items tagged as Medical Device

  • 2020-bl-connectivity-02_132x132

    A Q&A: the Trials and Triumphs of Validation

    Sequence Senior Consultant Peter McGrath weighs in on the struggles of traditional computer system validation (CSV), and how they can be solved with a risk-based approach. Months of time are spent on traditional CSV to the process, which produces piles of documentation. It doesn't have to be that way.

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  • 2021-bl-lean-documents_132x132

    Principles of Lean Documents

    Controlled documents tend to be weighed down with unnecessary information. When lean principles are applied to documentation practices, it becomes evident that most documents can be trimmed down to a comprehensive and useful level while maintaining compliance.

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  • 2020-bl-quality-excellence-02_132x132

    5 Critical Factors in the CAPA Process

    Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.

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  • 2021-bl-effective-failure-investigation_132x132

    Is Your CAPA Process Providing Adequate Return on Investment? If Not, Why Not?

    The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.

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  • 2021-bl-investigational-device_132x132

    FDA’s IDE: Data-Centric Approach to Med Device Innovation

    An Investigational Device Exemption (IDE) is a regulatory option that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This article explains why medical device manufacturers would seek an IDE and how they apply for the designation.

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  • 2020-bl-5-ways-2020-changed_132x132

    5 Ways 2020 Changed the Regulated Medical Industry

    With 2020 behind us, let’s take stock of what happened during the year and how the face of regulated medical industry has changed. Heading into 2021, be ready for remote options, deferred enforcement of regulations and more.

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  • 2020-bl-risk-based-approach-validation_132x132

    A Risk-Based Approach to Validation

    Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.

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  • 2020-bl-six-steps-qualifying-suppliers_132x132

    Five Best Practices for Ensuring Supplier Quality

    Managing various suppliers is complicated. Lapses in process or product quality along the supply chain can have a negative impact on the end product. This article includes five best practices for establishing more effective oversight of suppliers throughout the supply chain.

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  • 2020-bl-qarad-brexit_132x132

    Brexit and the Impact on the IVD and MD Industries

    On January 1, 2021 the United Kington will leave the European Union. The implications of this move have a significant impact on manufacturers.

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  • 2020-bl-managing-compliance-costs_132x132

    EU’s MDR Calls for Summary of Safety and Clinical Performance

    With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.

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  • 2020-bl-prepare-dhf-fda_132x132

    Is Your Design History File Prepared for an FDA Inspection?

    The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.

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  • 2020-bl-iso-13485_132x132

    Overview of ISO 13485 – Medical Device Quality Management System Requirements

    Medical device manufacturers tout ISO 13485 certification as proof that their quality management systems (QMS) and products are up to snuff. But what does compliance to the standard entail? Get answers to the most frequently asked questions about the world’s most widely used QMS standard for device companies.

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

    Australia Offers Wave of Potential for Pharma, Medical Device Manufacturers

    Gathering momentum and power like a monster wave, Australia's life sciences sector is increasingly becoming a beacon for pharmaceutical and medical device manufacturers seeking regulatory approval for their products.

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  • 2020-bl-therapeutic-goods-admin-guidance_132x132

    Software as a Medical Device – Upcoming Changes to the Australian Regulations

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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  • 2020-bl-thumb-design-control-process_132x132

    What Verification and Validation Activities are Required for a First in Human Study?

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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  • 2020-bl-thumb-qserveeu-mdr-update

    EU's MDR Extended: Where Do Medical Device Manufacturers Stand?

    The much-anticipated one-year delay of the European Union’s Medical Device Regulation (MDR) finally dropped earlier this month. Gert Bos, Executive Director and Partner of the Qserve Group, breaks down what this means for device manufacturers and for their preparations to recertify under the new regulation through a designated Notified Body.

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  • 2020-bl-thumb-med-device-ebook

    A Data-Centric Approach to Propel the Future of Device Innovation

    Technology and digital transformation are rapidly altering the way medical device manufacturers accelerate production and innovate new products. A new e-book “Mastering Data to Drive Medical Device Innovation to 2030” looks at how the medtech ecosystem is moving toward a more data-centric approach to quality manufacturing. Automated solutions integrated into a digital platform offer device makers the tools to generate real-time intelligence and insights that will lead to greater innovation over the next decade.

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  • 2020-bl-thumb-brandwood-fda-501k-trends

    What 2019 Data Reveals About FDA’s 510(k) Program

    The U.S. Food and Drug Administration's (FDA) 510(k) pathway for medical devices is aimed at simplifying and instilling more predictability in the regulatory process. This article examines 2019 data on manufacturers’ use of the regulatory pathway and looks at some trends and takeaways for device makers.

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  • 2020-bl-thumb-manufacturing-tech-trends-accelerate-time-to-market

    3 Trends That Can Improve Manufacturers’ Speed to Market

    Technologies are evolving and maturing, and regulatory bodies are reacting to remove unnecessary roadblocks for device companies while protecting consumer safety. Manufacturing organizations that embrace these opportunities will be better positioned to achieve significant efficiencies in product discovery and development, regulatory compliance and, ultimately, speed to market.

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  • 2020-bl-thumb-3-medical-device-trends

    3 Medical Device Trends for 2020

    Advanced technology, market growth and regulatory disruption are creating an opportunity-rich but also demanding medical device space in 2020. An overview of some of the most impactful medtech trends of 2020 gives companies insights on how the industry is evolving and offers ways to flourish in a more data-driven ecosystem.

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