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
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.
15 freelancer đang chào giá trung bình $1157 cho công việc này
Hello! I specialize in creating academic and scientific content. My clients hire me to write, proofread or edit scientific texts and manuscripts. I love my job and will gladly help you with your project.
16 years experience with Philips Cerner and Siemens healthcare. Expert in Software as medical devices. Please indicate your email and will send a detailed profile.