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TF Template

Guidance:

NB MED 2.5.1 Technical Documentation

Guidance Word Format:

NB MED 2.5.1 Technical Documentation

 

Product descrition and summary.

Intended use and operation.

 

Envisaged Manufacturing methods.

 

There are two main.

 

Accessories descriptions.

 

Device classification.

 

Applicable directives and standards.

 

Design Solution to comply with applicable directives and standards.

 

Evidence of compliance with the standards and directives.

 

Design risk assements.

 

Specification of materials and circuit diagram for components subassemblies and the complete product including packaging where appropriate.

 

The specifications of the checks, tests and trials that are intended to be carried out as part of routine production.

 

The performances and com- patibilities intended by the manufacturer.

 

Labelling, including any in- structions for use.

 

Identification of ‘shelf-life’ re- flected by any ‘use by’ date, or other ‘lifetime’ of the device(s).

 

Results of Bench Testing.

 

Clinical Data.

 

Documentation and reporting of Design Changes.

Risk assessments.