I will be your eu mdr consultant and write your clinical evaluation cer

Is your Medical Device ready for the new EU MDR?

The era of "self-certification" is over. The new Medical Device Regulation (MDR 2017/745) requires significantly more clinical evidence and safety monitoring than before. If your documentation is stuck in the old "MDD" era, your product will be blocked at the border.

I am a Regulatory Affairs Specialist with experience dealing with major Notified Bodies (TÜV SÜD, BSI).

My Core Service: The Clinical Evaluation Report (CER) Every device, even a simple bandage, now needs a CER. I write this for you by:

1. Literature Search: Searching medical databases (PubMed/Embase) for similar devices.
2. Appraisal: Analyzing safety data.
3. Report: Drafting the document following MEDDEV 2.7/1 Rev 4 guidelines.

I Support:

• Class I (Low Risk)
• Class IIa (Medium Risk)
• Software as a Medical Device (SaMD)

Why Me?

• ISO 13485 Aligned: I ensure all docs fit into your Quality Management System.
• Risk Management: I integrate ISO 14971 risk analysis into every document.

Protect your patient safety and your profits. Order the Standard Package for a compliant CER.