Annex I

Essential Requirements1

Product No:

Product Name:

Version: 1.0Approved by:

General statement:

This device is designed and manufactured to a quality system conforming to Medical Devices Directive 93/42/EEC Annexure II as amended by 2007/47/EC.

The [XXX Co] Quality Manual contains all relevant processes, procedures, and guidelines.

Where applicable, the relevant ISO, BS, and ASTM standards are used in the design process.

I. General requirements

To ensure that essential requirements 1–6 are met, the following standards have been used:

[Insert section – insert all the standards and guidelines you have used.]

[In the next table, ...

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