Why medical device companies fail with design and development inputs

Confused about ISO 13485 design and development inputs requirements? Join our upcoming training session to succeed where many organizations fail!
🎤 Featuring Peter Sebelius, ISO/TC 210 member & Medical Device HQ founder
Getting design and development inputs right is a regulatory must.
And ISO 13485 sets crystal clear expectations: Inputs must be complete, unambiguous, verifiable, and free of internal conflict.
Yet many organizations stumble here…
Join our upcoming training session with Peter Sebelius, member of the ISO/TC 210 committee and founder of Medical Device HQ and Angel Buendía, Scilife’s Knowledge Manager, where you will learn what design and development are required according to ISO 13485.
We’ll show you how to:
- Avoid common pitfalls: Hear real-world examples of vague specs and poor categorization and how to fix them.
- Write high-quality requirements: Get practical, proven patterns to make your inputs clear, consistent, and complete.
- Align with ISO 13485: Ensure your documentation meets the full intent of the standard with confidence.
📅 September 23d, 2025 | 11:00H (CET)
Don’t miss this chance to level up your compliance and design process with guidance straight from the source.