Write Clear Design Inputs: A Practical Guide to ISO 13485 Compliance

In the medical device industry, the clarity of your design and development inputs is vital. Unclear or conflicting requirements can slow down development and make it harder to meet regulatory expectations. This session offers practical guidance to help ensure your design inputs are clear, complete, and fully aligned with ISO 13485 standards.

In this webinar, industry expert Peter Sebelius, CEO and Trainer at Medical Device HQ, shares proven strategies for writing effective requirements. Discover how to avoid common mistakes and build a strong foundation for compliant, successful product development.

Key Takeaways:

• Identify and steer clear of the most common mistakes in requirements engineering, using real-world examples.
• Learn straightforward techniques to make your requirements clear and organized.
• Put proven patterns to work so your documentation is complete, audit-ready, and easy for all stakeholders to understand.
• Understand ISO 13485 expectations so your design inputs are unambiguous, verifiable, and consistent.

Walk away ready to write clear requirements and robust design inputs that stand up to ISO 13485 audits and set your team up for development success.