|Version: 1.0||Approved by:|
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
[Insert section – insert all the standards and guidelines you have used.]
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