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The Medical Device Developer's Guide to IEC 60601-1

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Click here for the IEC 60601-1 Primer, by Leonard Eisner, Robert M. Brown and Dan Modi, as published in "Medical Device and Diagnostic Industry"

Electrical Requirements

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Mechanical Requirements

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Consulting Services

601help offers Consulting Services in the Product Safety and Regulatory Fields.

Services available include:

     

    Product Development Review:

      We can review your development documents with respect to compliance with the regulatory requirements - catching a problem in the development stage can save time and money later.

     

    Pre-Audit Review:

      Do you have an audit coming up in the near future? You can make use of 601help's Pre-Audit Review Service. We will critically review your documentation e.g.

      • Quality Procedures
      • Technical Files
      • Responses to deviations

          BEFORE the Regulatory Authority sees them.

      The review will be with respect to appropriate requirements, such as ISO 9001, ISO 13485, IEC 60601-1, ISO 14971, Essential Requirements of the EU's Medical Devices Directive, etc.

     

    Technical File Review:

      Are you about to submit a Technical file for Type Approval?

      601help can review the file and help solve problems before the Regulatory Authority finds them.

 

To receive a price quotation for our Regulatory Consulting Services, e-mail us at services@601help.com with details of your requirements.

Disclaimer

 © Powerful Connections  2001-2007. All rights reserved

601help is a Trade Name of Powerful Connections Ltd.

The author thanks the International Electrotechnical Commission (IEC) for permission to use material from the IEC 60601-1 international standard . All extracts are copyright © IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC, its publications and its role is available from www.iec.ch. IEC takes no responsibility for and will not assume liability for damages resulting from the reader's misinterpretation of the referenced material referenced due to its placement and context in this publication.  The material is reproduced or rewritten with their permission.