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

Technical Documentation for Medical Device Industry
Technical documentation refer to the needed documentation set for each medical device. European MDR and IVDR provides an upper level 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 of needed documentation directly in regulations or in applicable guidance documents.
There are multiple subcategories in the documentation which all need some special expertise such as:
- qualification and classification
- requirement management
- risk management
- usability
- software
- medical electric safety
- biological safety
- IVD performance
- clinical evaluations
- clinical investigations
- performance evaluations (IVDR)
- performance studies (IVDR)
- in-house developed tests (IVDR)
Labquality’s experts provide assistance in understanding and defining the complexity of the documentation, planing the needed set of documentation and implementing the plan.
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How can we help?
Labquality can provide several levels of assistance for your technical documentation such as:
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
Explore our services

Electrical Safety IEC 60601
IEC 60601-1 is the basic safety standard for medical electrical devices and systems.
Biological Safety ISO 10993
We provide medical device manufacturers help with setting up a biological safety evaluation process and preparing biological evaluation documentation.
IVD Performance Evaluation
Labquality helps manufacturers comply with the clinical evidence requirements of the IVD Regulation.
Risk Management ISO 14971
Labquality provides medical device manufacturers help in setting up and implementing a risk management system and preparing risk management documentation.
Regulatory plan
Labquality can help medical device manufacturers in creating a regulatory plan.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
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.
Medical software
Labquality also provides comprehensive support for medical software lifecycle.