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Medical Devices CONSULTANT & Preparation of technical documentation as per NEW EU Regulations 2017/745 for Medical Devices

Hello

We are looking for some one preparation technical documentation as per NEW EU Regulations 2017/745 for Medical devices (MDR) for our products and assist us to apply for certification.

I know this may not be the right platform for this kind of project but there is no harm in trying.

you must have a good knowledge of

NEW EU Regulations 2017/745 for Re-Useable, Class I-R and we need someone to prepare the technical files for my products

TECHNICAL DOCUMENTATION

Preparation of technical documentation according to requirements of Medical Device EU Regulations 2017/745, harmonized standards. Technical Files shall comprise of

Assembly of Technical File [MDR, Annex II & NB-MED/2.5.1/Rec 5] & Process Flow Chart

Product, Parts, Material & Components Specifications

Risk Analysis Procedure & Report [EN ISO 14971]

Harmonised Standards Compliance Matrix [MDD, Article 5, EN IEC 60601-1, EN IEC 60601-1, EN IEC 60601-2-2]

Harmonised Standard Compliance Matrix [EN ISO 10993-1]

Essential Requirements Checklist [MDD, Annex I]

Labeling [MDD, Annex I & ISO 15223-1]

Declaration of Conformity [MDD, Annex II]

Classification & Procedure [MDD, Annex IX]

Instructions for Use (IFU) [MDD, Annex I, 13.1 & EN ISO-1041]

Justification(s) for any deviation from requirements of MDD

Please only contact if you have good knowledge of above and please only ask for more details if you you know how to deal with this.

Habilidades: Redação técnica, Engenharia

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Acerca do Empregador:
( 4 comentários ) accrington, United Kingdom

ID do Projeto: #20245777

15 freelancers estão ofertando em média $1157 para esse trabalho

pavi87june

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7.4
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6.2
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funnyhoney

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SidraSadaqat

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induvnair11

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