Document compilation

We'll lighten your load for you

When launching a new device the mountain of required documentation grows day by day. Do you have the necessary capacity to cope with it all on your own? We help you to create the requisite documentation for your devices and processes. This leaves you free to concentrate on the essentials.

Hands-on support with the management of your documents

• We help you to prove conformity with the essential requirements using a CE checklist.
• We create the technical documentation (e.g. in accordance with STED requirements) for your device or update your existing design dossier.
• We take care of the requisite expert opinions and evaluations of your devices and the materials used according to DIN EN ISO 10993-1.
• As your competent partner we check the instructions for use and the label for compliance with DIN EN 1041 and DIN EN 980 respectively.
• We update or prepare the clinical evaluation of your device in accordance with MEDDEV 2.7.1.
• We adapt the QM manual and your SOPs to your business processes in accordance with DIN EN ISO 13485 and support your quality management.

We support you in the creation of the G-BA (Federal Joint Committee) application for the admission of a prescribable medical device into Appendix V AMR (medicinal product guideline), or the application for admission into the catalogue of medical aids and appliances for reimbursement.