I will do prepare technical file, ce mark certification

I have knowledge of MDR (medical device regulation) for the CE marking of medical devices.

Devices can be classified into the following categories:

• Class I - generally regarded as low risk FOR CE MARKING
• Class IIa - generally regarded as medium risk FOR CE MARKING
• Class IIb - generally regarded as medium/high risk FOR CE MARKING
• Class III - generally regarded as high risk FOR MDR

Class I devices can be further split into three 'subclasses':

• Is - sterile device
• Im - device with a measuring function 
• Ir - is a re-usable device (i.e. surgical equipment)
• Related to Technical file toys , machine, surgical, dental, Instruments

Following Documents will be Provided under MDR in my service plan

1. Declaration of Conformity
2. Design & Manufacturing Information
3. General Safety & Performance Requirements
4. Harmonized Standard Compliance
5. Risk Management Plan
6. Risk Management Report
7. Verification & Validation Repor
8. Post Market Surveillance
9. Packaging & Labelling
10. CER Plan.
11. Undertaking.
12. Technical File Summary
13. CER (Clinical Evaluation)
14. BER (Biological Evaluation)
15. IFU