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QMS Implementation for Class III Medical Device

Introduction

Streamlining ISO 13485 Certification for a connected medical device.

The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking.

Apotech Team

  • Worked full time on the project: balanced position between coaching the internal team and being hands on when required
  • Prepared the QMS backbone
  • Supported the team in Authoring the SOPs
  • Organised and led the Risk Assessment workshops
  • A second consultant acted part-time as a sterilisation SME: supporting the client’s Team in their sterilisation process (ETO)
  • Risk assessment, SOPs writing, provider management (Quality agreement).

Standards & Tools

  • EU-MDR 2017-745
  • ISO 13485
  • ISO 14971
  • ISO 11137
Frame 1000005946

Scope of work

Done

QMS writing and implementation

Done

Training on QMS implementation

Done

Notified bodies relationship

Done

Risk assessment

Done

Sterility insurance

Done

The project was focused on the design and development activities.

Key numbers

Management

Team

1.5 FTE

Charity

Location

France

Combo Chart

Length

12 months

WeChat

Type

Time and Material

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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.