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
- 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.
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