Service Details
Technical Documentation
We prepare technical documentation for CE marking of medical devices and commercial and industrial products according to the Medical Device Regulation (MDR), Machinery Directive (MD), Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), and Radio Equipment Directive (RED).
Context and Introduction
Technical documentation provides evidence of a product’s design compliance with applicable regulatory requirements. In fulfilling this obligation, the manufacturer has the opportunity to formalize the attention given to developing a safe and effective product in the case of medical devices.
01
Medical Devices
Technical documentation provides evidence of a product’s design compliance with applicable regulatory requirements. In fulfilling this obligation, the manufacturer has the opportunity to formalize the attention given to developing a safe and effective product in the case of medical devices.
02
Commercial and Industrial Products
We prepare technical documentation for CE marking of commercial and industrial products according to the Machinery Directive (MD), Low Voltage Directive (LVD), Electromagnetic Compatibility Directive (EMC), and Radio Equipment Directive (RED).
03
Technical Activities
We support the manufacturer in formalizing specific contents of the technical documentation: risk management according to EN 14971 and ISO/TR 24971, usability engineering according to EN 62366-1 and IEC/TR 62366-2, formalization of the software life cycle according to EN 62304, and execution of clinical evaluation according to MDR art. 61.
04
Technical Consultations
We provide technical opinions and rationales in the context of legal disputes and in case of differences of opinion between the manufacturer and the notified body during the conformity assessment process.
05
Coordination
We coordinate conformity assessment activities by directly liaising with the notified body, testing laboratories, and any CROs, facilitating the completion of the process.
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Needs Analysis
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