Technical File Construction
To obtain CE marking manufacturers must prepare and keep technical documentation that states how each medical device was developed, designed and manufactured.
QbD will help you construct technical files that meet the requirements of your chosen Notified Body.
The right structure of documentation is essential
The way to set up the technical documentation is defined in the manufacturer’s quality system management (QMS). This process should not be underestimated. Extensive coverage of different sections may be created in different departments and/or locations. It is therefore essential that manufacturers keep a strict record of their technical files and update if changes are made.
Different Notified Bodies may prefer different technical file structures and may place emphasis on different aspects.
For example, TÜV in Germany may expect a very detailed technical file, whereas G-Med in France may concentrate on certain critical steps such as risk management and its incorporation in the overall quality system. The Global Harmonisation Task Force (GHTF, now the International Medical Device Regulators Forum – IMDRF) has published a guidance document in order to harmonize dossier requirement.
Checklist of essential requirements
Medical devices must meet the essential requirements which apply to them, taking into account the device’s intended purpose. Each technical file/design dossier should contain a list of essential requirements. This is usually presented in the form of a checklist:
- The Essential Principles
- Whether each Essential Principle applies to the device and if not, why not
- The method(s) used to demonstrate conformity with each Essential Principle that applies
- A reference for the method(s) employed (e.g., standards), and
- The precise identity of the controlled document(s) that offers evidence of conformity with each method used
Methods used to demonstrate conformity may include one or more of the following:
- Conformity with recognised or other standards
- Conformity with a commonly accepted industry test method(s)
- Conformity with an in-house test method(s)
- The evaluation of pre-clinical and clinical evidence
- Comparison to a similar device already available on the market
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