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I will do ukca certification amazon ebay


Gabriel Iso
Level 2
5.0
5.0
Acerca de este Servicio
I have knowledge of MDR (medical device regulation) for the UKCA marking of medical devices.
Devices can be classified into the following categories:
- Class I - generally regarded as low risk FOR UKCA MARKING
- Class IIa - generally regarded as medium risk FOR UKCA MARKING
- Class IIb - generally regarded as medium/high risk FOR UKCA 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 UKCA MDR in my service plan
- Declaration of Conformity
- Design & Manufacturing Information
- General Safety & Performance Requirements
- Harmonized Standard Compliance
- Risk Management Plan
- Risk Management Report
- Verification & Validation Report
- Post Market Surveillance
- Packaging & Labelling
- CER Plan.
- Undertaking.
- Technical File Summary
- CER (Clinical Evaluation)
- BER (Biological Evaluation)
- IFU
Conoce a Gabriel Iso
Gabriel Iso
Level 2
- DePakistán
- Miembro desdeene 2023
- Responde aprox. en:1 hora
- Última entrega3 semanas
Idiomas
Inglés, Urdu, Árabe
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lylia_khan

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Professional work for getting CE certification and Technical Documentation Highly recommended!!!
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Más relevante
L 
lylia_khan

Argelia
Professional work for getting CE certification and Technical Documentation Highly recommended!!!
Hasta USD50
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2 días
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A 
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Útil?

