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GMP Subject Downloads

Medical Devices
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GMP requirements for medical devices
120 Pages
ISBN: 978-3-943267-25-9
   x
Medical devices comprise a wide variety of product types. GMP requirements for these products must thus cover a wide range of manufacturing procedures and operations. It is therefore understandable that there are no standardized and specific instructions for the manufacturing of medical devices. Current provisions and standards do not mandate in detail the manufacturing process for a medical device.

Table of Contents:
- Introduction (definition, types of medical devices, regulatory background)
- Quality Management System
- Personnel
- Design control
- Human factors
- Statistical techniques
- Risk management
- document and record control
- production and process controls
- identification and traceability
- buildings, facilities and equipment
- validation
- purchasing/supplier control
- packaging and labeling
- handling, storage, distribution, installation and servicing
- nonconformance, corrective action and preventive action
- customer complaints
- combination products

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Dr. Katherine M. Wortley
Associate Director Strategic Regulatory Affairs

Sherry Leichtweis
Divisional Vice President, Strategic Regulatory Affairs

Dr. Volker Lücker
Law Office Lücker MD-Law, Germany
Excerpt from the GMP MANUAL. Identical with chapter 23.
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