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Medical Device

MedTech Buyer's Guide

Buyer’s Guide for MedTech

What will help MedTech companies stay competitive in an era marked by rapid innovation, rising regulatory complexity, and global disruption?  As the industry moves toward smarter, more personalized, and increasingly connected healthcare, MedTech manufacturers face mounting pressure to reduce time to market, improve patient outcomes, control costs, and ensure compliance without sacrificing quality or patient…

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  • Buyer's Guides

Michelle Boucher - September 17, 2025 - Filed Under: Published Research, Buyer's Guides, eBooks - Tagged With: PLM, ALM, Medical Device, MedTech, Regulatory Compliance, Buyer's Guide

MedTech ALM and PLM

MedTech: ALM and PLM Better Together

What should MedTech companies consider when integrating ALM and PLM? Software has become a crucial component in MedTech products. However, with software development managed in Application Lifecycle Management (ALM) and hardware managed in Product Lifecycle Management (PLM), the separate systems can create silos within the product development team. With increasing regulatory pressures and trends such…

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  • Webinars

Michelle Boucher - May 20, 2025 - Filed Under: Webinars, Presentations & Videos - Tagged With: Medical Device, MedTech, Embedded Software, Digital Thread, Med Device, Compliance, PLM, ALM, Digital Thread Integration

Medical Device Innovation

Enlil Focuses on Accelerating Medical Device Innovation with Compliance

We were recently alerted to a company we weren’t covering because a long-time business friend took a key position there. After a quick review of what they do, Julie Fraser and Jim Brown decided to team up on the briefing because we could already see a combination of QMS and PLM capabilities. We learned that…

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  • Insights

Jim Brown - May 12, 2025 - Filed Under: Insights, Insights & Activity - Tagged With: Approval, FDA, Compliance, MedTech, PLM, Class 2, Product Development, Class 3, Manufacturing, Clearance, NPD, Quality Management, Product Innovation, Medical Device, Traceability

Connected Medial Devices

How Connected Medical Devices Will Revolutionize Healthcare

Will connected medical devices make the Star Trek medical tricorders a reality in healthcare? A few decades ago, Star Trek’s tricorders were complete science fiction – only in the imagination could a device perform a simple scan and offer a full medical diagnosis of any ailment. While we may not be quite there yet, today’s…

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  • In the News

Michelle Boucher - June 11, 2024 - Filed Under: In the News, Insights & Activity - Tagged With: Product Innovation, Connected Devices, Medical Device, Healthcare, Life Sciences, Smart Products, IoT

Accelerate Manufacturing

Accelerate Manufacturing and Time to Market in Life Sciences

How can life sciences manufacturers accelerate their innovation? One way is by recognizing and creating an operational digital twin that’s connected to MES. We will discuss: How digital twin of operations and MES support rapid innovation while ensuring high-quality, compliant, and cost-effective operations Why manufacturing matters through the lifecycle of life sciences products starting in…

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  • Webinars

Julie Fraser - April 26, 2023 - Filed Under: Presentations & Videos, Webinars, Slideshow - Tagged With: Biotech, Compliance, Quality by Design, Manufacturing, Quality, Time to Market, MES, Medical Device, Life Sciences, Pharmaceutical, Digital Twin

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