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ERAS Leadership in Medical Device Innovation
Introduction The Enhanced Recovery After Surgery (ERAS) protocol is transforming perioperative care, reshaping how surgical recovery is...
Gniewomir Gordziej
20 kwi 20249 minut(y) czytania
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Upcoming Changes to Machinery Regulation - Involvement of Notified Bodies in CE Marking Process
In a significant regulatory update, a new machinery directive mandates the involvement of notified bodies in the conformity assessment...
Gniewomir Gordziej
18 kwi 20244 minut(y) czytania
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Practical Guidance on NPDP Certification for Future Product Leader
The New Product Development Professional (NPDP) certification is a credential that recognizes the expertise and knowledge of...
Gniewomir Gordziej
28 lut 20247 minut(y) czytania
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Premature Solutions in Product Development
At the heart of successful product development lies a profound empathy for the user, coupled with a rigorous approach to identifying and...
Gniewomir Gordziej
22 lut 20246 minut(y) czytania
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Setting Up Pillars of Operational Excellence with TRIZ Methodologies
Background The Theory of Inventive Problem Solving, better known by its Russian acronym TRIZ, is a systematic approach developed in the...
Gniewomir Gordziej
20 lut 20245 minut(y) czytania
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Impact of ISO/IEC 62304 on New Machine Regulations and Software Lifecycle Documentation
The integration of software into medical devices and machinery has significantly advanced the capabilities and functionalities of these...
Gniewomir Gordziej
17 lut 20244 minut(y) czytania
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NanoHeal - Wound Recovery with Nanofibers
Nanotechnology is making significant strides in the realm of healing wounds, with nanofibers at the forefront of this innovative wave....
Gniewomir Gordziej
15 lut 202411 minut(y) czytania
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Bringing Ideas to Life - Understanding NPD Beyond R&D
Introduction Many companies often conflate New Product Development (NPD) with Research & Development (R&D), yet recognizing their...
Gniewomir Gordziej
11 lut 20244 minut(y) czytania
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The 2027 Transition from the Machinery Directive to the New Machinery Regulation - Embrace the Change by Early Shift
Introduction The Machinery Directive and the updated Machinery Regulations are both European Union (EU) legislative tools designed to set...
Gniewomir Gordziej
10 lut 20246 minut(y) czytania
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Unsuccessful Performance of NPD Teams - From Planning Pitfalls to Scope Creep
# Introduction Product development is a complex and multifaceted process that lies at the heart of innovation and business growth. In a...
Gniewomir Gordziej
27 sty 202410 minut(y) czytania
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The Impact of the European Commission's AI Regulation on Medical Devices
# Introduction Artificial intelligence (AI), a transformative force in the modern era, has seamlessly woven itself into the fabric of...
Gniewomir Gordziej
28 gru 20239 minut(y) czytania
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Navigating the ISO 13485 Certification - Strategies and Insights
The medical device industry operates within a landscape of stringent regulations, exacting standards, and an unwavering commitment to...
Gniewomir Gordziej
16 lis 202326 minut(y) czytania
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Innovate or Protect? The Art of Disclosing Wisely in Open Innovation
# Background In an era characterized by rapid technological advancements and global interconnectedness, the traditional boundaries of...
Gniewomir Gordziej
11 lis 202316 minut(y) czytania
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The Environmental Impact of Medical Technology: Sustainable Solutions
# Introduction The healthcare industry has made tremendous strides in saving lives and improving patient care through medical technology....
Gniewomir Gordziej
1 lis 202316 minut(y) czytania
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EU MDCG Guidance on Medical Device Software and Hardware Component Integration
The European Commission's Medical Device Coordination Group (MDCG) has released guidance aimed at assisting manufacturers of hardware and...
Gniewomir Gordziej
25 paź 20233 minut(y) czytania
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Unlocking Seamless Connectivity: The Era of Service-Oriented Device Connectivity (SDC)
# Introduction and Background The rapid proliferation of the Internet of Things (IoT) has catalyzed a paradigm shift in the way devices...
Gniewomir Gordziej
17 paź 202316 minut(y) czytania
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Open Innovation (OI) in Emerging Technologies: The Next Frontier
# Background The pace of technological advancement in the 21st century is nothing short of astonishing, reshaping our lives, societies,...
Gniewomir Gordziej
9 paź 202310 minut(y) czytania
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Steps for Getting a Custom-made Medical Device (CMD) into the Market
# Introduction Promoting personalized medical equipment presents a formidable task, entailing adherence to numerous regulatory...
Gniewomir Gordziej
3 paź 20238 minut(y) czytania
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Roadmap Mastery: Crafting Stellar Product Strategies
# Background: In the dynamic landscape of modern business, effective product development is a cornerstone of success. A product roadmap...
Gniewomir Gordziej
29 wrz 202332 minut(y) czytania
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Mastering Product Information Management (PIM): Your Path to Data Excellence
Setting up a Product Information Management (PIM) process is crucial for organizations that deal with a large catalog of products. PIM...
Gniewomir Gordziej
14 wrz 202321 minut(y) czytania
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