--- title: "From Code to Conformity: workshop for medical devices" description: Medical Devices Software Training from Firefinch Software and Lucendra MedTech Consulting image: https://hello.firefinch.io/hubfs/11-25-DSC06724-1.jpg --- [Skip to content](https://hello.firefinch.io/code-to-conformity#main-content) [![Firefinch\_Logo\_Red\_White\_RGB](https://hello.firefinch.io/hubfs/Firefinch_Logo_Red_White_RGB.png)](https://firefinch.io/) English # ![9ebe31eb-0251-4b53-8216-bf0a3642e475](https://hello.firefinch.io/hs-fs/hubfs/9ebe31eb-0251-4b53-8216-bf0a3642e475.png?width=491&height=126&name=9ebe31eb-0251-4b53-8216-bf0a3642e475.png)         # From Code To  Conformity: # Medical Device Software Workshop   ### Practical software development for medical devices under EU MDR/IVDR and the AI Act   --- ## Who should attend? This free, full-day workshop with Firefinch, Lucendra MedTech Consulting and TÜV SÜD is designed to leave you with actionable insights to avoid costly rework, a clearer understanding of what regulators actually expect, and the confidence to move forward with the right plan for your device or IVD software.    Practical software development for; - Founders - Product owners/technical leads - QA professionals developing software for medical devices or in vitro diagnostics.   ## Why attend? Firefinch Software are developers, experts and strategists specialising in the life sciences. Lucendra MedTech Consulting are engineers, scientists and business professionals with expertise across the whole device lifecycle, from design and validation through regulatory approval to launch.  You’ll leave with:  - Actionable insights on avoiding rework - A clearer understanding of regulatory expectations - Confidence to move forward with the right plan - A partner who can support you every step of the way NB As places are limited, we may have to limit space to 1 per company.          **This workshop is accredited for 6 RAPS RAC/RCC recertification credits. Learn more about the RAC/RCC at www.raps.org.** ## What we will cover... #### The regulatory landscape for medical device software (EU vs US) Product qualification and classification; regulatory landscape in EU and US, commonalities and differences   #### Practicalities of EU MDR/IVDR conformity assessment What are the key process steps and what are the common mistakes to avoid   #### IEC 62304 in practice Integration of software development practices with medical device regulatory requirements   #### EU AI Act in relation to MDR/IVDR: compliance and post-deployment monitoring How the AI Act layers and integrates with MDR/IVDR   #### Risk management for software and AI-enabled devices How to apply ISO 14971 to software, and how AAMI TIR 34971 can be used to facilitate risk management of AI/ML-enabled medical devices   #### Cybersecurity for connected medical devices, including STRIDE   Plus practical exercises on software architecture, safety classes and threat modelling. You will also have time to ask the experts all the questions you may have.   --- ## Register your place below: ### Wednesday 18th November   ## Alanine meeting room, Biopôle, Lausanne   ### 9:00 – 17:00 ### Workshop & lunch   [![Register for Lausanne](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/19650546/bc59ed7e-f8e1-45c2-bf01-ccf003b56243.png)](https://hubspot-cta-redirect-eu1-prod.s3.amazonaws.com/cta/redirect/19650546/bc59ed7e-f8e1-45c2-bf01-ccf003b56243) --- ![Firefinch Logo](https://hello.firefinch.io/hs-fs/hubfs/Firefinch_Logo_Red_White_RGB.png?width=239&height=67&name=Firefinch_Logo_Red_White_RGB.png) ## About Firefinch Software Firefinch Software develops custom software for life science companies. Our expert-led development team combines deep scientific domain knowledge with regulatory compliance and strategic insight to help you build the right product, ready to scale. #### **Strong domain expertise**. Firefinch deliver solutions in medtech, biotech and medical devices and with companies ranging from start-ups to large multi-nationals. We take pride in delivering excellent client outcomes while strengthening clients' core capabilities. #### **Your software team for hire**. Firefinch can provide an entire cross-functional product team or can embed senior consultants with existing teams to strengthen their delivery capability. All projects are supported directly by a senior consultant and offer access to the skills of the entire team no matter the size of the project. #### **Built for long-term success**. The Firefinch team adapt to the client's needs. From the code to control a device through to cloud platforms for interacting with your data, we are experts at end-to-end solutions aimed at both external customers and internal business users. ![Lucendra Logo](https://hello.firefinch.io/hs-fs/hubfs/9ebe31eb-0251-4b53-8216-bf0a3642e475.png?width=239&height=61&name=9ebe31eb-0251-4b53-8216-bf0a3642e475.png) ## About Lucendra Lucendra are a full service medtech consulting company. The art of combining expertise in engineering, science, regulatory affairs, and business strategy to support all aspects of medical device development – from prototypes to certification and market approval – while maintaining a strong focus on compliance at every stage. ## Expertise Lucendra offer our clients expert support across a wide range of medical devices, including In Vitro Diagnostic devices and Combination Products, spanning from low-risk to high-risk classifications. Our expertise extends to various medical specialties, including neurology, cardiovascular, orthopedics, dentistry, ophtalmology, gastroenterology, oncology, (robotic) surgery, rehabilitation, gynecology, anesthesiology and more. 💠Substance-based Medical Devices 💠Combination Products 💠(Active) Implantable Medical Devices 💠In Vitro Diagnostic Medical Devices 💠Medical Device Software 💠Active and Wearable Medical Devices ## Can't attend? Let's connect!![Photo of Isabel Vincent](https://hello.firefinch.io/hs-fs/hubfs/IV%20Web.jpg?width=261&height=261&name=IV%20Web.jpg) If you can’t join us at the roadshow but still want to learn more, book a 1-to-1 meeting with Isabel Vincent, our Market Development Manager at Firefinch Software. Isabel trained in parasitology and metabolomics at Glasgow University and Université Laval in Québec, and holds a Master’s in Public Health. She’s led innovation projects in biotechnology (IBioIC), deep technology (EIT Deep Tech Talent Initiative), the circular economy (EIT’s Girls Go Circular), and food innovation (Prozymi Biolabs). Now, Isabel works directly with life science teams like yours to understand your challenges and show how Firefinch can help. [![Arrange a call](https://hubspot-no-cache-eu1-prod.s3.amazonaws.com/cta/default/19650546/bd0f2a5b-2e56-46bc-b72b-70d18e6b1f8d.png)](https://hubspot-cta-redirect-eu1-prod.s3.amazonaws.com/cta/redirect/19650546/bd0f2a5b-2e56-46bc-b72b-70d18e6b1f8d) ## Our Capabilities ![DESKTOP DEVICE CONTROL SYSTEMS](https://hello.firefinch.io/hs-fs/hubfs/FF-Web-Icon_desktop.png?width=200&height=186&name=FF-Web-Icon_desktop.png "DESKTOP DEVICE CONTROL SYSTEMS") DESKTOP DEVICE CONTROL SYSTEMS ![FF-Web-Icon\_Cloud](https://hello.firefinch.io/hs-fs/hubfs/FF-Web-Icon_Cloud.png?width=200&height=193&name=FF-Web-Icon_Cloud.png "FF-Web-Icon_Cloud") CLOUD-BASED APPLICATIONS ![ALGORITHMS & SIGNAL PROCESSING](https://hello.firefinch.io/hs-fs/hubfs/FF-Web-Icon-Algorithms.png?width=200&height=200&name=FF-Web-Icon-Algorithms.png "ALGORITHMS & SIGNAL PROCESSING") ALGORITHMS & SIGNAL PROCESSING ![DATA ANALYSIS](https://hello.firefinch.io/hs-fs/hubfs/FF-Web-Icon-Analytical.png?width=200&height=200&name=FF-Web-Icon-Analytical.png "DATA ANALYSIS") DATA ANALYSIS ![MACHINE LEARNING & AI](https://hello.firefinch.io/hs-fs/hubfs/FF-Web-Icon-AI.png?width=200&height=200&name=FF-Web-Icon-AI.png "MACHINE LEARNING & AI") MACHINE LEARNING & AI ## Client Success  ![Hart Biologicals Logo](https://hello.firefinch.io/hs-fs/hubfs/Hart-transparent-400x250.png?width=309&height=193&name=Hart-transparent-400x250.png) ##### *"Firefinch has been a critical partner in the development of our new Medical Device. The team integrated seamlessly with our Technical and Design teams to develop a user-friendly, modern looking software that is safe and accessible for the modern Point-of-Care market. Regulations for Medical Devices and software vary widely from country to country and Firefinch was a great help in making sure we are compliant in all our target markets. We really appreciated their communication and openness with our team members that led to friendly and robust cooperation between our teams which ultimately helped to deliver a great product."* ### -Alexander Ebinger, Hart Biologicals ### Read about the HART client journey and others [Read Our Case Studies](https://firefinch.io/case-studies/) [![Firefinch\_Logo\_Red\_White\_RGB](https://hello.firefinch.io/hubfs/Firefinch_Logo_Red_White_RGB.svg "Firefinch_Logo_Red_White_RGB")](https://firefinch.io) [mailto:contact@firefinch.io](mailto:contact@firefinch.io) © 2026 Firefinch Software SC557226 Theme developed by [GiantFocal](https://www.giantfocal.com/)