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  Root Cause Analysis for Medical Device Development

  Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.

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  5 Key Features of FDA Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

  Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework

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  Impact of New FDA Laboratory Developed Tests Policy

  The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.

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  5 Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges

  Drug Delivery Solutions for Cell and Gene Therapy (CGT) Challenges explores effective delivery devices and solutions for advanced CGT therapies and their unique challenges.

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  Medical Device Innovation Initiatives

  We design medical devices and our medical device innovation initiatives support the energy and shared passion when team members work together in person.

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  How eLearning and LMS Empower Medical Device Employees

  elearning and LMS improve an employee’s ability to learn and adhere to the company QMS for medical device design and development.

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  Sharing and Using SuperPowers and Kryptonite

  Our SuperPowers and Kryptonite program will continue to develop over time. It fosters a culture where people are inspired and able to do the most fulfilling work of their lives.

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  Validating Filter Integrity for Biopharmaceutical Manufacturing

  Filter Integrity Biopharmaceutical Manufacturing explores the relationship between microbial retention tests and integrity tests essential for validating the effectiveness of filters in critical applications.

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  FDA Guidance on Biocompatibility Evaluation ISO 10993-1

  Review of FDA Guidance on Using ISO 10993-1 integrating biocompatibility evaluation within the risk management process, as outlined in the FDA Guidance Document  Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process.

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