Compliant Technical Documentation (often referred to as Technical File) is a prerequisite for all medical device approvals and audits of Quality Management Systems (QMS).
The term refers to the complete set of documents that a medical device manufacturer must submit to all Regulatory and Auditing Authorities and is a requirement for most types of conformity assessments around the world.
Notified BodiesRegulatory and Auditing AuthoritiesEuropean Authorities
Creating robust clinical and technical documentation is crucial to demonstrating your compliance with the MDR. It requires thorough understanding of regulatory requirements and of Notified Body expectations in order to prevent delays in the certification process.
Publication of the new MDR has considerably increased requirements with respect to Technical Documentation that is submitted to European Authorities, which must now be structured as per Annexes II & III.
On the other hand, Technical Documentation for MDSAP audits mainly focuses on QMS aspects and not on the assessment of a device’s safety and performance.
Whether looking for a STED format or a customized structure, we provide a full spectrum of services to cover key areas of Technical Documentation such as:
With Evnia, your organization’s personnel, involved in compiling technical documentation, will:
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