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Prosthesis manufacturer

Introduction

Global API Manufacturer

As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months.

Types

MDSAP Audit Preparation, Quality Management System Review

Frame 1000005946

Scope of work

Done

Selecting the certification body (quotes, Q&A)

Done

Review of their quality management system

Done

Remediation implementation

Done

Preparing for the MDSAP audit

Done

Mock MDSAP audit

Done

Staff training on MDSAP requirements

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Client quote

Apotech's guidance in navigating the MDSAP audit process was invaluable. Their expertise not only led us through the compliance journey, but their method to select the certification body was also very much appreciated.

Key numbers

Management

Team

1 MDSAP specialist and 1 MDSAP lead auditor

Charity

Location

France

Combo Chart

Length

6 months

WeChat

Type

MDSAP audit preparation

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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.