From Code to Conformity Workshop - Medical device software

Practical workshop for founders, product owners/technical leads and QA/RA professionals developing medical device/IVD software.

Who should attend?

This free, full-day workshop with Firefinch and Lucendra MedTech Consulting 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.

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.

A light lunch will be provided and certification will be provided to attendees that successfully complete the workshop.