Welcome to the internal download area for Ottobock employees!
Here you will find templates and other helpful documents and information explicitly tailored to the needs of the Ottobock Patient Care Clinics with regard to custom-made products.
All the material you find here is for internal use only!
The precondition for achieving MDR compliance is the fulfilment and implementation of the already applicable 93/42/EEC (MDD) regulations.
The templates that you can download here serve to adapt your already existing processes with regard to custom-made products so that they are MDR-compliant. If individual processes are not yet established in your company, the templates can be used to their full extent with only a few adjustments.
Ottobock Headquarters provides you with content; this reduces effort and costs for the entire group.
Each individual Patient Care Clinic is obliged to review all documents used and release them locally. You must adapt the templates to fit your local quality management system or processes. You, in particular your Person Responsible for Regulatory Compliance (PRRC or Article 15 person), are the document owner and responsible for the content as well as for the implementation of the processes.
In this section we share the presentations that have been prepared as part of the MDR Q&A-Sessions.
Trainings and more
In this section we share further supporting information.
Templates & Documents
Select a product group in your language and find templates for
- Clinical Evaluation
- PMS File (= Post Market Surveillance)
- Risk Management File
- GSPR Checklist acc. to Annex I (EU) 2017/745 (General Safety and Performance Requirements)
Select the folder SOPs to download standard operating procedures for the four required processes.
Download the folder Generic templates to receive further supporting documents, independent from any product group.