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

Our experienced professionals help medical device manufacturers develop regulatory plans that support their entire product lifecycle.

Technical documentation

All medical devices must have documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and developing your 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

The international standard for the 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 national law.

IVD performance evaluation

In vitro diagnostic medical device (IVD) regulations are set in the EU In Vitro Diagnostics Regulation (IVDR).

Qualification and classification of medical devices

Our team’s versatile experience and the available tools help in bringing clarity to the most challenging cases.

Medical software

Let our experts help you understand and adhere to medical device software regulations throughout the entire lifecycle.

Risk management ISO 14971

We can help you setup and implement a risk management system and prepare risk management documentation.

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Technical Documentation