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Drivers of Consolidation Trend in Medical Technology: A Holistic Examination
# Introduction The field of medical technology has undergone significant transformations in recent years, driven by technological...
Gniewomir Gordziej
13 wrz 202311 minut(y) czytania
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Materials Magic: Pioneering the Future of Medical Devices
The field of materials technology is undergoing a remarkable transformation, and it's poised to revolutionize the world of medical...
Gniewomir Gordziej
9 wrz 202327 minut(y) czytania
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Design Control 101
# Introduction For businesses involved in the manufacturing of medical devices or software integrated into medical devices (SaMD or...
Gniewomir Gordziej
6 wrz 20236 minut(y) czytania
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Navigating Change in the Medical Device Industry: A Critical Imperative
In the ever-evolving landscape of medical device companies, the way they manage change plays a key role in shaping their operations. This...
Gniewomir Gordziej
1 wrz 20235 minut(y) czytania
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Human Factors Engineering for Medical Device Design - Anticipated Trends
# Background Human Factors Engineering (HFE) should be an integral consideration for all medical device manufacturers throughout the...
Gniewomir Gordziej
30 sie 20234 minut(y) czytania
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Recent Developments in ISO 10993: An Overview of Updates and Changes
# Introduction At the IME East event held in New York, Thor S. Rollins, Vice President and Global Market Segment Leader for Medical...
Gniewomir Gordziej
29 sie 20233 minut(y) czytania
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Japan's Latest MHLW Guidelines Identifying Software as Medical Devices
The healthcare sector has witnessed a rapid surge in the development and market introduction of groundbreaking products and services,...
Gniewomir Gordziej
28 sie 20233 minut(y) czytania
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Comprehending the 2022/23 Cybersecurity Guidelines for Medical Devices by the FDA
# Background With the implementation of fresh cybersecurity protocols for medical devices by the FDA, set to be rigorously enforced from...
Gniewomir Gordziej
24 sie 20237 minut(y) czytania
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Establishing an Efficient Framework for New Product Development: Essential Attributes
# Introduction In the dynamic contemporary business environment, adeptly crafting and introducing new products has emerged as a defining...
Gniewomir Gordziej
22 sie 202311 minut(y) czytania
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Switzerland Explores Importing U.S. FDA-Approved Medical Devices Amidst EU Market Access Challenges
Switzerland explores importing U.S. FDA-approved Medical Devices amidst EU Market access challenges and regulatory implementation...
Gniewomir Gordziej
21 sie 20235 minut(y) czytania
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Selected success factors in Requirements Management
The evolution of Requirements Management (RM) has been substantial. Initially, RM might have commenced as a rudimentary product concept...
Gniewomir Gordziej
18 sie 20239 minut(y) czytania
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