• Risk-Based Postmarket Surveillance In The Age Of EU MDR

    As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. Jayet Moon, author of the book Foundations of Quality Risk Management, takes a bottom-up approach to PMS with this e-book.

  • Risk Based Approaches To Establishing Sample Sizes For Process Validation

    This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. Process validation is one of the most commonly cited 483 Inspectional Observations issued by the FDA. The citations often reveal the organization failed to “ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure” (21 CFR 820.75 – Process validation).

  • Identifying And Resolving Errors, Defects, And Problems Within Your Organization

    As I write this foreword, it's in isolation amid the SARS-CoV-2 global pandemic. While it's clear that eventually this current global response will lift, it makes me think of Heraclitus' quote, "Change is the only constant." We all within this and every industry, endeavor to get back to full productivity, which requires production. When production happens, so to do procedural errors. This guide is a critical look at the best and most fundamental methods I have employed over many years to help innumerable companies prosper. 

  • Drug Delivery Insights For The Medical Device Industry

    Whether you’re trying to coax a toddler into taking cough medicine or puzzling out how best to introduce a large-molecule biologic, each drug delivery scenario presents unique challenges. Teams developing the drug must work hand-in-hand with teams developing the delivery device, ultimately agreeing on the proper combination of elements to best serve the intended patient pool — a process that weaves together decisions concerning biocompatibility, container size and shape, delivery mechanism, human factors engineering, and countless other elements. In this eBook, our editors have assembled insights from some of the experts in this field among our editorial contributors.

  • Data Integrity In The Life Sciences

    This eBook is a collection of articles from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

  • Medical Device Cybersecurity

     

    3D printing is establishing its criticality to the life sciences industry more every day. Used to create anatomically precise models for surgery preparation, to craft prostheses and medtech prototypes, and now even proving its salt as a viable option for mass-produced components, the ceiling for this technology is limitless. In this eBook, Med Device Online has assembled insights from some of the experts in this field among our editorial contributors.

  • Considerations For Drug Delivery Device and Combination Products

    Drug delivery devices and combination products are evolving by the day —more compact and portable, more user-friendly, more robust, and more accessible to varied patient populations than ever before. In this eBook, Med Device Online has collected wisdom from some of the experts in this field among our editorial contributors.

  • 3D Printing and Prototyping in Medical Device

    3D printing is establishing its criticality to the life sciences industry more every day. Used to create anatomically precise models for surgery preparation, to craft prostheses and medtech prototypes, and now even proving its salt as a viable option for mass-produced components, the ceiling for this technology is limitless. In this eBook, Med Device Online has assembled insights from some of the experts in this field among our editorial contributors. 

  • Regulatory Insights For Global Medtech Operators

    What is our readers’ greatest shared concern? Demystifying the constantly evolving regulatory landscape each medical device must navigate before it can help patients. Learn more in this free collection of articles highlighting how regulatory confusion can be time-consuming, costly, and damaging to your brand.