Medical Device Design Control

Compliance and quality are paramount in the medical device industry regulated by MDR/IVDR, ISO 13485 and the US QMSR (FDA). Our experts guide you through the design control process, implement rigorous product risk management, and develop verification/validation plans, protocols, and reports with statistical rationales. Emendo can support you in all steps – from user needs, device requirement and specification. We can also assist in the dialogs with the Notified Body to obtain the CE marking.

For combination products, Emendo provides support in e.g. writing documentation compliant with product standards such as ISO 11608 and ISO 11040.

Services include:

• Write and review required technical and quality documentation, e.g. verification/validation
• Design stability studies incl. justification of sample sizes
• Statistical data analysis
• Risk assessments in accordance with ISO 14971