Technical Documentation

We support you in the preparation of technical documentation for obtaining the CE marking of medical devices

Depending on the classification, medical devices must be certified by a notified body. In order for the product to be included in the scope of approved products, it requires complete technical documentation in accordance with Directive 93/42/EC.

Our services:

Manage and coordinate a project and/or support your team in processing various tasks.
Design technical documentation in accordance with regulatory requirements.
Establish or review a document plan.
Determine applicable guidelines and standards.
Develop and introduce a risk management process.
Plan and implement V&V activities for the product and the associated manufacturing processes Carry out
Review labels and operating instructions
Review required biocompatibility evidence
Support in the preparation of the clinical assessment

Your benefit:

The content and scope of the technical documentation correspond to the expectations of the notified body.
The certification process is accelerated.