Medical Device Technical Documentation
We understand technical documentation as the document or its set that develops the properties, characteristics and design and development process in relation to the medical device manufactured by the company.
The technical documentation of the medical device must be prepared by the manufacturer. It will be clear, unambiguous and orderly, while also being easy to search for and retrieve.
You will have a description of the product, with its specifications and the patients or users to whom it is addressed, including its variants and complements.
It will always refer to previous generations of product, if any, and will contain the product information that the manufacturer must provide with it.
The product documentation shall also contain the information, and history, of the design and development of the product, its technical specifications and the exact identification of the sites and suppliers and/or subcontractors involved in the life cycle of the product.
The technical product documentation shall also contain the requirements applicable to the product, as well as the justification for their compliance.
It will also contain the necessary documents that provide the risk management of the product, including the risk/benefit analysis of the same.
Clinical evaluation of the product
The technical documentation will also include the clinical evaluation of the product, as well as the clinical data that support it, as well as the verification and validation of the product.
Additional documentation
In addition, it shall include all additional documentation required to document full compliance with the applicable requirements.
At PS Consulting we have specialized in medical device documentation requirements, please contact us.
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