ISO 13485 Starter Kit

The QMS for your medical device.

4'150 CHF plus VAT

  • Build a strong QMS tailored to your business needs.
  • Secure ISO 13485 certification with a system designed using our longstanding regulatory expertise and experience. 
  • 2-hour consultation call to assess and tailor relevant QMS elements to your business and confirm the content for your system. 
  • 4-hour on-site workshop to develop the QMS process map and confirm the implementation strategy.
  • 2-hour training session for your team in the QMS and audit process.
  • 4-hour mock audit to confirm system readiness and ensure certification.
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Description

This package is designed to help start-ups build a strong and secure quality management system (QMS) tailored to your business needs. The ISO 13485 Starter Kit is built to ensure your QMS meets your regulatory requirements for certification as this standard defines a QMS as the basis for compliance in the development, manufacturing and trade of medical devices. Developed using the full scope of our in-depth expertise and longstanding experience, the ISO 13485 Starter Kit is the fastest and most direct route to building an effective and efficient QMS. This package includes a 2-hour consultation call, 4-hour on-site workshop, 2-hour training session and a 4-hour mock audit, to give you both a secure system and fully trained team for audit readiness. For clients accessing the European market we will integrate QMS requirements under the EU’s MDR / IVDR free of charge.

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