Build Your ISO 13485 Quality System Independently and With Confidence
The ISO 13485 Self-Starter Pack is designed for medical device businesses that want to implement a compliant quality management system independently, at their own pace.
It provides all the essential procedures, templates and forms required by ISO 13485, structured in a practical, step-by-step format that makes implementation achievable for small and growing teams.
Who is this for?
The Self Starter Package is ideal for:
- Start-ups preparing for certification
- Small medical device or IVD manufacturers, wholesalers & distributors
- Importers & distributors building formal QMS structures
- Businesses transitioning from ISO 9001 to ISO 13485
What’s Included in the Pack?
- Document Control Procedure
- Record Control Procedure
- Management Review Procedure
- Post-Market Surveillance Procedure
- Training and Competency Procedure
- Risk Management Procedure
- Supplier Control Procedure
- Complaint Handling Procedure
- Internal Audit Procedure
- CAPA Procedure
How it Works?
- Download the pack
- Review and customize documents
- Train your team
- Implement processes
- Conduct internal audit
- Prepare for certification
PNS MED HEALTH 