Technical Documentation

Technical Documentation

Due to the extension of the MDR deadline, we can support our customers to certify even more of their products under the new regulation. Beginning with the classification of complex and borderline products, we help our customers to select the best regulatory pathway. Our technical writers review the existing documentation and perform a gap analysis. With smart testing strategies tailored to the specific device we ensure minimal testing effort. Our engineers and scientist interpret the test results and formulate consistent technical documents to be submitted to the notified body.

We provide you with

Identification of the gaps in the technical documentations and developing strategies for efficient gap closing

Classification of complex / borderline medical products according the new Medical Device Regulation

Risk analysis according ISO 13485, including proposal of risk reduction and management measures

Writing and reviewing of technical documentation according to MDR requirements and company quality system

Design of most effective testing strategies tailored to the specific device, notified body requirements and stage of development

Direct communication with notified bodies and fast responses to specific issues

Conception of MDR compatible post market surveillance concepts


What is your challenge?