Yallow Life Science: Design & Development Essentials Course

Contact Mohammad Albatat (COO & Partner) for registration and more information: mohammad.albatat@yallow.no

Scope:

A general and practical one-day course designed for development teams.
The focus is on how different processes interact and coordinate with each other, such as risk management, usability, design inputs and outputs, verification, validation, and change control and how these can easily be handled as part of one integrated process.

The course builds on the principles of ISO 9001, ISO 13485, EU MDR (2017/745), and FDA 21 CFR 820/QMSR, showing how teams can maintain compliance while keeping development agile and efficient.

Purpose:

To give development teams a clear understanding of process interaction and dependencies throughout the product lifecycle, and practical tools for integrating quality and regulatory requirements into everyday development work.

Time and duration:

Wednesday 26th of November 2025 (09:00 – 16:00)

The agenda will come later.

Location:

Forskningsparken and Online (Teams)

Price:

4 500 NOK per participant
(Includes course materials, certificate, lunch and refreshments)

Key Topics:

Interaction between design, risk, and usability processes

Integrating risk management (ISO 14971) and usability engineering (IEC 62366)

Design inputs and outputs — creating a clear traceable flow

Verification and validation (V&V) made simple and compliant

Design transfer and change control as part of the same process

Overview of ISO 9001, ISO 13485, MDR (EU 2017/745), and FDA 21 CFR 820

How to align cross-functional teams and documentation efficiently

Best practices and common mistakes