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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.

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Technical documentation for Healthcare Industry

Technical documentation refers to the needed documentation set for each medical device. European MDR and IVDR provide 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 cybersecurity. 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:

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

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Electrical Safety IEC 60601

Electrical Safety IEC 60601

IEC 60601-1 is the basic safety standard for medical electrical devices and systems.
Biological Safety ISO 10993

Biological Safety ISO 10993

We provide medical device manufacturers help with setting up a biological safety evaluation process and preparing biological evaluation documentation.
Regulatory plan

Regulatory plan

Labquality can help medical device manufacturers in creating a regulatory plan.
Qualification and classification of medical devices

Qualification and classification of medical devices

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

Contact us for more information

Meeri Säily
Sales Director, Consulting and Clinical Trials

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