Articles From Our Expert Network

91. ISO's Updated 22442 Animal Tissue Standards — What Changed? 9/29/2020

    This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).

92. ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices 9/28/2020

    This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.

93. A Methodology For Developing Injection-Molded Plastic Parts For Your Medical Device 9/21/2020

    This article describes a methodology that addresses the questions that have a reputation for being “troublemakers” in the process of injected plastic product development, without compromising innovation and creativity.

94. Generate The Right Input Data For A Quality Management Review System 9/21/2020

    In this part two in a series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems, we turn our attention to the input data for an effective quality management review.

95. "Quality Culture" And CGMP Compliance: The Perception-Vs-Reality Gap 9/16/2020

    This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.

96. Incorporating Privacy By Design & Security By Design Into Medtech Development 9/2/2020

    Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.

97. Making FMEA More Robust With HACCP 8/27/2020

    Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

98. Discovering & Motivating Talent In The Life Sciences: Redefining “Other Duties & Responsibilities” 8/21/2020

    How do we attract the right kind of talent to a role within our organizations? How do we take the same innovative approaches in our talent acquisition processes that we put into our products? One answer can be found in an often-overlooked bullet point in a common job description: “other duties and responsibilities as required.”

99. Incorporating Injection Molded Plastics In Medical Device Design — Initial Considerations 7/29/2020

    Even a great component idea can be undermined by gaps in knowledge surrounding plastic materials, from engineering and design considerations to optimal procedures for turning that idea into a reliable plastic part that can be consistently produced, affordably and with high quality.

100. MDR's Impact On The European Trauma Device Market 7/20/2020

     The MDR could prove detrimental to the EU trauma device market, while COVID-19’s impact should be minimal. Will key market drivers be enough to prompt growth?