Showing items tagged as Medical Device

  • 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?

    Full story
  • 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.

    Full story
  • 2021-bl-culture-of-quality_132x132

    6 Ways Quality Managers Can Build a Culture of Quality

    If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?

    Full story
  • artificial-intelligence-132

    AI: Regulatory Framework for SaMD – Part Two

    The U.S. Food and Drug Administration (FDA) has proposed a regulatory framework around Artificial Intelligence/Machine Learning (AI/ML) for software as a medical device (SaMD). In the second part of a two-part series, past and current regulations are explored and explained.

    Full story
  • 2021-bl-medical-device-dhf_132x132

    Overview of the Medical Device Design History File, Technical File, and Design Dossier

    Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.

    Full story
  • 2021-bl-brandwood_132x132

    Transition Plan: From Custom Device to Patient-matched

    As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
  • 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.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]