Industry Perspectives - Design & Development
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3 Ways The Agile Method Unlocks Rapid Innovation In Medtech
3/15/2024
Scheduling daily team huddles, killing deadlines, and making space to reflect and grow are all agile teamwork elements that contribute to rapid innovation in medtech. Here's why.
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6 Things Medtech Companies Should Know About The EU’s AI Act
3/4/2024
With the recent publication of the European Union’s long-awaited Artificial Intelligence Act (AI Act), the message to medtech companies is clear: you need to move toward compliance by understanding your AI systems, determining their role under the AI Act, and identifying the specific obligations and implementation strategies that apply.
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New FDA QMSR Through The Lens Of Risk Management: Requirements And Analysis
2/29/2024
On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
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Using Relational Risk Analysis To Control Procedure Failures
2/15/2024
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
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Getting Out Of The Doldrums: Analyzing & Kickstarting Organizational Quality Maturity
2/8/2024
It's difficult to consider what the impact of organizational culture might be on a quality system, its effectiveness and robustness, and even its maturity state. You need a way to spot when your team is in the doldrums and kickstart quality maturity. Regulators want it, so you should, too.
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5 Focus Areas For Medtech Business Success In 2024
2/8/2024
Medtech manufacturers able to manage today's uncertainty and change will seize on new opportunities through innovation. Successfully navigating this landscape requires proactive consideration of these 5 focus areas.
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Use-Related Risk Analysis For Combination Products
2/7/2024
One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions.
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Foundational Human Factors Engineering Concepts For The Design Of Combination Products
2/5/2024
How can companies keep pace with the demand in the combination products market while meeting or exceeding regulatory expectations of applying human factors engineering? This article provides an overview.
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Secure By Design And Default: Compliant Medical Device Development
1/8/2024
The Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI, and international partners issued recommendations for tech manufacturers to ensure product security and, thereby, assist medical device designers and manufacturers in meeting the quality system cybersecurity considerations mandated by the FDA.
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The 10 Guiding Principles Of GMLP Identified By The FDA, HC, And MHRA
12/21/2023
The U.S. FDA, Health Canada (HC), and the U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) have come together and identified 10 guiding principles, with the aim of developing good machine learning practices (GMLP) that will address the unique nature of AI/ML-driven medical devices.