Streamlining ISO 13485 Certification for a connected medical device
Introduction
Our client is a startup at the forefront of connected health technology (diabetes)
Types
Quality Management System Implementation, ISO 13485 Certification
Scope of work
Apotech's comprehensive support included a preliminary gap analysis, development and implementation of quality management systems tailored to the unique needs of a connected device, and guidance through the certification process.
Key numbers
Team
2 consultants
Location
Tech hub in Europe
Length
14 months
Type
Quality management system development
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