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

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Consulting Services - Click here to check out 601help's Regulatory Consulting Services

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 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, contact us with details of your requirements.