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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

Frame 1000005946

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.

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CEO, ConnectMed

Apotech's expertise in ISO 13485 was invaluable in building our quality management system from the ground up. Their tailored approach not only facilitated our certification but also embedded a culture of continuous improvement and compliance within our team.

Key numbers

Management

Team

2 consultants

Charity

Location

Tech hub in Europe

Combo Chart

Length

14 months

WeChat

Type

Quality management system development

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Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.