ISO 13485 Implementation guidance for Startups

Implementation is where 90% of companies fail, not because they lack documents, but because they lack direction.

In this 4-hour hands-on session, I don’t just explain ISO 13485; we build your implementation roadmap.

We’ll cover:

• Gap analysis – where your current operations stand vs ISO 13485 requirements.
• Designing your QMS structure (Document control, Management Responsibility, Resource Management, Product Realisation, Measurement & Improvement).
• Creating document templates for SOPs, records, master lists, CAPA, NCR, Internal Audits, etc.
• Integration with IMDR 2017 requirements for Indian compliance.
• Supplier management and risk-based thinking implementation.

Value to your company:

You’ll leave with a customised implementation plan, clear ownership of each clause, and document templates you can immediately adapt.

This session converts theory into action, positioning your company for audit readiness, license application, and investor confidence.