Softacus

29/04/2025

🩺 The medical device industry is entering a new regulatory era in 2025. Are you ready?

With evolving requirements in both the U.S. and Europe, medical device manufacturers are facing increased expectations around clinical evidence, post-market surveillance, and software lifecycle management. 📈

While these changes bring challenges, they also open up opportunities for companies to strengthen quality systems, enhance patient safety, and accelerate innovation through better data and digital traceability.

📃 At Softacus, we work closely with medical technology companies to ensure their tools and processes are aligned with regulatory frameworks like MDR, FDA, and IEC 62304 — helping them stay compliant while remaining agile.

To learn more, read this article:
👉 https://www.mpo-mag.com/new-medical-device-regulations-in-2025-opportunities-and-challenges/

hashtag hashtag hashtag hashtag hashtag hashtag

What will the regulatory environment look like this year? How can medtech manufacturers set business goals or seize opportunities for new market growth?

25/04/2025

🚀 Upcoming Webinar: Reuse of Requirements in Product Line Engineering
🗓 28 April 2025 | 🕒 15:30 CET

How can you reduce duplication, accelerate development, and enable smarter product configuration?

In this live session, we’ll explore how IBM DOORS Next Generation (DNG) supports efficient reuse of requirements across product lines — helping your teams shift focus from repetitive tasks to true innovation.

🔍 What you’ll learn:
✅ How to structure and manage reusable requirements
✅ How platform-based development speeds up delivery
✅How IBM DNG enables scalable, configurable product design

💡 Get practical insights into making your requirements strategy more efficient, flexible, and future-ready.

👉 Secure your spot now: https://zoom.us/meeting/register/NxbhzcKSQ9uwsS3LWEOqRw

11/02/2025

🚀 Navigating IBM DOORS Classic to DOORS Next Generation Migration? Join Our Expert-Led Webinar!

Are you considering or currently navigating the migration from DOORS Classic to DOORS Next Generation? The transition can be complex—but with the right approach, it doesn’t have to be.

Join us for a live webinar where we’ll break down the migration process, best practices, and expert insights to ensure a seamless, efficient transition.

📅 Webinar Details:

📌 Date: 25 February 2025

📌 Time: 3:30 PM (CET)

📌 Location: Online (Live Webinar)

Why Attend?

✅ Learn how to automate Global Configurations for efficiency

✅ Explore advanced migration techniques (views, custom link types & more)

✅ Understand the two main migration processes & when to use each

✅ Gain insights from real-world success stories & best practices

✅ Get expert tips to avoid common migration pitfalls

This session is designed for systems engineers, IT leaders, and requirements management professionals looking to transition without unnecessary headaches.

🚀 Secure your spot now! https://zoom.us/meeting/register/ocRKOfVyR2S-lZW30mYx6w

Looking forward to seeing you there!

09/01/2025

🚗 The Future of Automotive: What’s Next?

The automotive industry is rapidly evolving, with electrification, connectivity, and autonomous driving shaping its future.

Software-defined vehicles (SDV) and sustainability are driving innovation, redefining how we think about cars and mobility.

📖 Read this article to find out the 5 key trends shaping the automotive industry in 2025: https://www.techinsights.com/blog/five-key-trends-automotive-2025

📈 Which trend do you think will transform the industry the most by 2025?

TechInsights has identified five key trends that will define the automotive electronics landscape in 2025 and beyond. These insights are essential for industry stakeholders navigating this rapidly shifting terrain.

07/01/2025

Managing complex projects in the medical industry is no easy task—balancing thousands of requirements, stringent regulations, and multiple stakeholders can feel overwhelming.

But what if you could simplify it all?

With IBM Engineering Lifecycle Management (ELM), you can:

✅ Achieve end-to-end traceability across requirements, hazards, risks, tests, and workflows.
✅ Generate automatic documentation and reports, saving valuable time.
✅ Ensure built-in compliance, reducing risks and costs.
✅ Accelerate time-to-market with improved efficiency and precision.

Empower your projects with a single integrated platform trusted by leading medtech innovators.

🔗 Discover how IBM ELM can transform your innovation journey: https://softacus.com/solutions/solutions-for-systems-and-software-development-for-medical-devices

Or connect with our experts today at [email protected]



https://www.youtube.com/watch?v=QEoQVdB-yQI

Develop medical devices with high quality by leveraging reuse concepts, collaboration, traceability, and full compliance to medical standards.

03/01/2025

🎉Happy New Year! 🎉

We wish all of you peace, prosperity, and happiness in every moment of 2025! 🌟

24/06/2024

✨"You can always keep working, you can always keep improving."

Monday Motivation: A Day in the Life of a Systems Engineer

Check out this inspiring video by Collins Aerospace showcasing the challenges and the rewarding aspects of a Systems Engineer's work.

🎥 https://www.youtube.com/watch?v=62JHMPImI4Q

What drives you in your role as a Systems Engineer?

Julie Byrd is a senior systems engineer in our Government Systems business in Cedar Rapids, IA.Her most recent assignment is on the Tactical Combat Training ...

13/06/2024

What our long-standing customer Webasto - one of the largest suppliers to the automotive industry worldwide, says about working with Softacus:

"Thanks to the strategic partnership with Softacus and the trust that has been built up, projects can be implemented efficiently and with little administrative effort.

A continuous improvement process is a matter of course for Softacus. In case of problems in the operation of the systems, Softacus reacts quickly and brings the necessary experts to the table."

At Softacus, we pride ourselves on building strong, trust-based relationships with our clients, allowing us to deliver high-quality solutions and services.

Learn more at https://softacus.com/

11/06/2024

🩺Struggling to maintain compliance in your medical device development business? Our IBM ELM solution can help!

🌡️ As medical devices grow in complexity, IBM helps you strike a balance between rapid innovation and compliance with regulations, such as:

•IEC 62304

•FDA Design Controls (21 CFR P. 820.30)

•FDA electronic records & signatures (21 CFR P. 11)

•EU MDR

With IBM Engineering Lifecycle Management 💊, you can handle system requirements, establish traceability, maintain rigorous quality control, classify risks, ensure hazard mitigation, and guarantee quality through thorough testing.

🔬 Implement innovation, manage changes, versions, and more.

Explore further and request a demo 👇 https://softacus.com/solutions/solutions-for-systems-and-software-development-for-medical-devices



https://www.youtube.com/watch?v=lLYAtKSQcX8

🩺 Create top-notch medical devices using proven concepts, collaboration, traceability, and full compliance with medical standards. 🌡️As devices grow in com...

03/06/2024

✨ Thanks to everyone who joined our recent webinar on migration from IBM DOORS Classic to DOORS Next with Rustam Zaidullin!

Whether you're considering making the transition or simply eager to learn more about the benefits, we hope you found the session insightful.

During the webinar, we covered key topics such as:

🔗 Custom link types usage for migrated links - defining link types based on source and target object's module path in DOORS Classic or DOORS Next. 📊 Creation of nested Global Configurations structure - leveraging DOORS Next streams and baselines created during migration.

🔍 Flexible definition of artifact types - using a dedicated enumeration attribute or conditions built on queries for more attributes.

📧 Missed the session? Just drop us an email to [email protected] and we will be happy to send you the recording!

Stay tuned for future webinars and further insights.

10/05/2024

Are you considering using IBM System Design Rhapsody for your software and system modeling? 🖥️

Or do you want to enhance your experience with the tool? 💡

Whether you're new to IBM Rhapsody or an experienced user, Softacus offers various training options: Foundation, Practical, and Advanced 📚 to kickstart your journey into productive multi-user modeling based on SysML or UML.

Thanks to our size and agility, we can often tailor training to fit your needs!

Learn more: https://softacus.com/products/application-lifecycle-management/rational-rhapsody/training

🚀 Elevate your knowledge about IBM Rhapsody! Contact us today: https://softacus.com/about/contact 📩

06/05/2024

How often do you use templates in your work? 📝

A template is like a magic wand that streamlines your tasks and saves time ⏳. It's the blueprint for efficiency, automating steps in your project workflow and boosting productivity.

If you're considering using IBM DOORS® Next Generation or already do, understanding templates is crucial. Learn about their types, management, and even how to create your own in our latest article!

Check it out here: https://softacus.com/blog/articles/dng/templates-in-dng

📩 For more information about Softacus services and DNG widgets, drop us an email to [email protected] 📧