What is it?
Technical documentation serves as evidence of compliance with regulatory requirements and is typically submitted as part of the regulatory approval process for medical devices. The technical documentation provides information on the design, manufacture and operation of a device. It helps regulators, healthcare professionals, and end-users understand the device's intended use, functionality, and safety considerations.
The requirement for technical documentation for medical devices and IVDs is specified in Annexes II and III of the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic medical device Regulation (EU) 2017/746 (IVDR), respectively.
Here at QuikQuality, our consultants will help develop your technical documents step by step ensuring that your product meets the regulatory requirements and ensuring patient safety.
What are the services we provide under technical documentation?
Build technical documentation / medical device file
Conduct gap assessment on existing device
Gap closure on existing device
General/Ad hoc consulting