• gmp-verlag.de
  • GMP MANUAL Login
  • Shopping cart
Shopping cart
Your shopping cart is empty

Show shopping cart...
Stay informed!

If you’d like to be regularly informed on the latest developments in Good Manufacturing Practices


>>> REGISTER for our free GMP Newsletter LOGFILE

GMP Subject Downloads

Medical Devices
€ 129.00
€ 153.51
  19% VAT included
pdf download
GMP requirements for medical devices
120 Pages
ISBN: 978-3-943267-25-9
Excerpt from the GMP MANUAL

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

Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
  • After payment is received an email with the download information will be sent.

If you choose payment by credit card:

  • Immediately after the credit card payment you will receive an email with the download information.
  • The invoice will be sent by postal mail as soon as possible.

Technical Requirements

This file is in PDF format! To view these files, you need Adobe Reader installed on your computer. If you don't, you will need to download and install it.

>>> Adobe Reader - free download

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
GMP Glossary and Abbreviations
GMP Audit Checklist (Download)