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.
Who audits Technical Documentation
Notified Bodies Regulatory and Auditing Authorities European Authorities
What you need to be successful
Creating robust technical documentation is crucial to demonstrating compliance with the MDR and IVDR. 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 & IVDR 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.
How Evnia helps
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:
Verification and validation testing (including process validation)
Usability engineering testing
Biological Evaluation Plans and Reports as per ISO 10993 (in conjunction with ISO 14971 and EU-MDR requirements where applicable)
Risk Management Files, including
Evaluation of risk acceptability
Risk Management Report as per ISO 14971, AAMI TIR97, 21 CFR Part 820, MDR/IVDR, MDSAP QMS P0005 requirements (whichever is applicable)