Technical documentation

Technical Documentation for the Medical Device Industry

Technical documentation refers to the required documentation determined for each medical device. European MDR and IVDR provides an overview list of required documentation in Annexes II and III. There are more detailed requirements available in applicable standards, like ISO 13485 for Medical Device File requirements, and guidance documents, like MDCG 2019-16 for cyber security. Other markets also provide information on needed documentation directly in regulations or in applicable guidance documents.

There are multiple subcategories in the documentation which requires specialized backgrounds:

How can we help?

We provide several levels of assistance for your technical documentation:

creating GAP analysis of your current technical documentation
for new products/projects, supporting in planning the needed set of documentation
supporting in creation of all technical documentation entities

Regulatory plans

Regulatory plans for medical device manufacturers.

Technical Documentation

All medical devices must have a set of documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and creating the needed Technical Documentation.

Electrical Safety IEC 60601

IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.

Biological Safety ISO 10993

International standard of biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.

IVDR compliance for in-house developed tests

Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.