The ISO 13485 standard sets clear expectations for design and development inputs. These inputs must be complete, unambiguous, able to be verified or validated, and free from internal conflict. Many organizations fail to write requirements that meet these criteria, so in this webinar, Peter Sebelius, member of the ISO/TC 210 committee (which authors ISO 13485) and founder of Medical Device HQ, will clarify what the standard truly requires when it comes to design and development inputs.
You’ll learn how to:
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Avoid common pitfalls: Learn from real-world cases of vague specs and inconsistent categorisation.
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Write high-quality requirements: Use proven patterns to make requirements clear, consistent, and complete.
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Align with ISO 13485: Make sure your inputs fully meet the standard’s expectations; complete, unambiguous, verifiable, and conflict-free.
