BioSistemika

04/06/2026

Does the CRA apply to your software? If you've been asking yourself that question, you're not alone.

Over the past few weeks, we invited you to submit your questions about the 𝗘𝗨 𝗖𝘆𝗯𝗲𝗿 𝗥𝗲𝘀𝗶𝗹𝗶𝗲𝗻𝗰𝗲 𝗔𝗰𝘁 (𝗖𝗥𝗔).

The response exceeded our expectations. We received a lot of practical questions, such as:
• Does the CRA apply to SaaS platforms?
• What about software that runs completely offline?
• Can we self-certify, or do we need a Notified Body?
• Do security updates really have to be free?

Read Part 1 here: https://hubs.ly/Q04jYS-w0

A big thank you to everyone who submitted questions and participated in the campaign.

26/05/2026

Are you still creating pipetting plans on paper or in Excel, and spending extra time double-checking for pipetting errors?

Discover 𝗣𝗶𝗽𝗲𝘁𝘁𝗶𝗻𝗴 𝗔𝗶𝗱 𝗣𝗹𝗮𝘁𝗥: a tablet application that helps make manual pipetting more accurate, efficient, and stress-free. With guided well illumination directly on your microplate, PlatR shows you exactly where to pipette next.

Create your pipetting plan in the app, follow the illuminated wells, and pipette with confidence.

Watch the video to see PlatR in action: https://hubs.ly/Q04hNCSz0

Manual pipetting is a time-consuming and exhausting process. Use PlatR and eliminate your pipetting mistakes.PlatR is a digital pipetting tool. It guides you...

20/05/2026

𝐔𝐩𝐜𝐨𝐦𝐢𝐧𝐠 𝐜𝐡𝐚𝐧𝐠𝐞𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐚𝐧𝐝 𝐈𝐕𝐃 𝐌𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐫𝐬!

Since the European Commission proposed a major simplification of the MDR and IVDR in December 2025, the industry has been closely watching its progress.

But beyond the headlines of saving the industry €3.3 billion annually, reducing administrative burden and improving innovation pathways, what could these proposed changes actually mean for the software behind your laboratory instruments and diagnostic devices?

We’ve broken down the proposal and highlighted some of the most relevant changes for your software development roadmap:
𝐒𝐦𝐚𝐫𝐭𝐞𝐫 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐂𝐥𝐚𝐬𝐬𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧: Classification rules are being revised, acknowledging that many software devices were previously pushed into higher risk classes by default, regardless of their actual clinical impact.
𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞𝐝 𝐀𝐈 𝐑𝐮𝐥𝐞𝐬: The proposal aims to reduce overlapping requirements between MDR/IVDR and the EU AI Act for AI-based medical devices.
𝐂𝐲𝐛𝐞𝐫𝐬𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐀𝐥𝐢𝐠𝐧𝐦𝐞𝐧𝐭: Clearer reporting structures are being introduced for actively exploited vulnerabilities and cybersecurity incidents, further aligning MDR/IVDR with the Cyber Resilience Act.
𝐆𝐫𝐞𝐚𝐭𝐞𝐫 𝐓𝐫𝐚𝐧𝐬𝐩𝐚𝐫𝐞𝐧𝐜𝐲 𝐢𝐧 𝐎𝐮𝐭𝐬𝐨𝐮𝐫𝐜𝐞𝐝 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Manufacturers may need to identify external software development partners in Eudamed and ensure proper oversight of technical documentation.
𝐀𝐝𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐑𝐞𝐥𝐢𝐞𝐟 𝐟𝐨𝐫 𝐒𝐌𝐄𝐬 𝐚𝐧𝐝 𝐎𝐫𝐩𝐡𝐚𝐧 𝐃𝐞𝐯𝐢𝐜𝐞𝐬: The proposal also introduces fee reductions, more flexible compliance pathways, and administrative relief measures designed to support smaller manufacturers and highly specialized devices.

While the proposal is still moving through the EU legislative process, now is the right time to review your software architecture, technical documentation, and compliance strategy.

Read our latest blog post to understand the full impact of the proposed changes: https://hubs.ly/Q04h9qWv0

15/05/2026

Acquiring an ELN company is very different from selecting an ELN for your lab.

Beyond features and usability, acquisition decisions involve market positioning, integration potential, product overlap, compliance alignment, user adoption, and long-term business strategy.

One of our recent projects involved helping a client evaluate whether merging an ELN platform with their existing EHS solution made strategic and commercial sense.

The assignment:
• Benchmark leading ELN vendors
• Evaluate integration and compatibility potential
• Capture real user expectations from academia and industry
• Deliver a clear strategic recommendation within six weeks

The result was a 110-page strategic analysis that supported a successful merger and helped shape the client’s future product direction.

What made this project particularly interesting was that the final decision ultimately came down to a very simple question: Should they move forward - yes or no?

Behind that answer was extensive market research, vendor evaluation, competitive analysis, and user-driven insights.

Read the case study: https://hubs.ly/Q04gzkgb0

If your company is exploring ELN acquisitions, platform integrations, or expansion into connected digital lab ecosystems, this case study offers a practical look at how structured market intelligence can support strategic decision-making and reduce risk.

07/05/2026

𝗛𝗮𝘃𝗲 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻𝘀 𝗮𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗘𝗨 𝗖𝘆𝗯𝗲𝗿 𝗥𝗲𝘀𝗶𝗹𝗶𝗲𝗻𝗰𝗲 𝗔𝗰𝘁 (𝗖𝗥𝗔)?

The CRA introduces strict, mandatory cybersecurity requirements for software and connected products placed on the EU market. Many companies are still figuring out what this means in practice.

From vulnerability management and incident reporting to “secure by design” development and long-term software maintenance, the new regulation brings major changes for software vendors and regulated industries alike.

𝗧𝗵𝗶𝘀 𝗶𝘀 𝘆𝗼𝘂𝗿 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆 𝘁𝗼 𝗮𝘀𝗸 𝗼𝘂𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝘀 𝗱𝗶𝗿𝗲𝗰𝘁𝗹𝘆. Our next Ask Our Experts campaign is dedicated entirely to the𝗖𝘆𝗯𝗲𝗿 𝗥𝗲𝘀𝗶𝗹𝗶𝗲𝗻𝗰𝗲 𝗔𝗰𝘁.

How does the CRA impact software vendors in life sciences and regulated environments? What does "security by design" actually look like in practice? How should companies approach vulnerability handling, CE marking, patching, and lifecycle support?

Ask your question: https://hubs.ly/Q04fM8LQ0
You can also submit your questions anonymously.

We’ll gather your questions by May 20, share them with our experts, and provide their insights in a dedicated article. Don't miss this opportunity for free, first-hand expert advice.

24/04/2026

𝗔𝗿𝗲 𝘆𝗼𝘂 𝗿𝗲𝗮𝗱𝘆 𝗳𝗼𝗿 𝗖𝘆𝗯𝗲𝗿 𝗥𝗲𝘀𝗶𝗹𝗶𝗲𝗻𝗰𝗲 𝗔𝗰𝘁 (𝗖𝗥𝗔)?

The Cyber Resilience Act (CRA) introduces new, mandatory cybersecurity requirements for products with digital elements in the EU. While many teams are aware of it, it is often still seen as a regulatory or documentation exercise. In reality, it directly impacts how products must be designed, built, and maintained.

This raises a key question: how to align existing products and processes with these requirements without slowing down development or introducing unnecessary complexity?

To support this, our expert Anže Videnič, Head of Software Engineering, shares a 𝐬𝐭𝐫𝐮𝐜𝐭𝐮𝐫𝐞𝐝 𝐨𝐯𝐞𝐫𝐯𝐢𝐞𝐰 𝐨𝐟 𝐭𝐡𝐞 𝐂𝐑𝐀 𝐚𝐧𝐝 𝐢𝐭𝐬 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥 𝐢𝐦𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬:
• Who the CRA affects and why
• How it impacts your product lifecycle and responsibilities
• What concrete steps do you need to take to prepare

We have also included a 𝗽𝗿𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗰𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁 to help you assess your current state and identify gaps:
https://hubs.ly/Q04cTvJz0

22/04/2026

This year’s , it’s worth looking at how everyday lab practices shape sustainability.

In most laboratories, sustainability isn’t defined by a single big decision but by many small ones made every day. How data is recorded, how workflows are structured, how equipment is maintained - all of these actions together shape resource use, efficiency, and waste.

Here are some practical ways to make your laboratory more sustainable:
• Reduce energy consumption across equipment and operations
• Use resources wisely and apply the “reduce–reuse–recycle” principle
• Establish clear waste management practices across the lab
• Maintain equipment to extend lifespan and reduce environmental impact
• Optimize processes to minimize errors, repetition, and unnecessary work
• Build a culture that supports sustainable decision-making

You can explore these practices in more detail in our blog article: https://hubs.ly/Q049qbXr0

Combined with digital tools that improve data management, traceability, and workflow efficiency, these steps can help laboratories move toward more sustainable operations.

How sustainable is your laboratory?

20/04/2026

We’re at ESCMID Global 2026 in Munich!

As one of the leading events in the IVD and life sciences space, it’s the perfect place to connect, exchange ideas, and explore what’s next for the industry.

If you’re attending, reach out to our team - Jana Erjavec, Cinzia Tarducci, Urška Čepin, and Matevž Cesar - and discover how BioSistemika’s custom software solutions can support your work.

From Research-Use-Only tools to audit-ready IVD applications, we combine technical expertise with deep regulatory know-how to help you move faster and stay compliant.

20/04/2026

Last chance to catch our spring offer: 𝟭𝟬% 𝗱𝗶𝘀𝗰𝗼𝘂𝗻𝘁 𝗼𝗻 𝗮𝗹𝗹 𝗣𝗹𝗮𝘁𝗥 𝗽𝗮𝗰𝗸𝗮𝗴𝗲𝘀!

𝐏𝐢𝐩𝐞𝐭𝐭𝐢𝐧𝐠 𝐀𝐢𝐝 𝐏𝐥𝐚𝐭𝐑 is a trusted laboratory tool designed to support reliable and precise manual pipetting. It is especially beneficial for reducing pipetting errors, increasing productivity, and improving overall laboratory efficiency. PlatR is widely adopted in ELISA, PCR, and qPCR workflows, as well as in NGS library preparation.

Request a quote on our website to secure your 10% discount on all PlatR packages: https://hubs.ly/Q049qfGx0

But hurry, the offer is only available until April 30, 2026.

16/04/2026

ESCMID Global 2026 is just around the corner! We will be attending on April 19-20.

Will you be there as well?

Connect with our team - Jana Erjavec, Urška Čepin, Cinzia Tarducci, and Matevž Cesar - for a coffee or a short meeting.

Let’s discuss how we can support you in:
• Meeting product launch timelines through full ownership of software development
• Developing custom software for IVD medical devices in compliance with ISO 13485 and IEC 62304
• Upgrading legacy systems to meet 21 CFR Part 11, GxP, and IVDR requirements
• Designing robust software architectures for laboratory equipment and diagnostics
• Developing custom machine learning solutions for diagnostics and lab automation
• Preparing audit-ready documentation for regulatory certification
• Advancing laboratory process automation and digital transformation

See you in Munich!