I will write a professional iso 13485 audit report

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amosgideon226
A
amosgideon226
Amos M Gideon

Level 1

Algumas informações são exibidas no idioma inglês.

Sobre este Serviço

Are you a busy ISO 13485 auditor with fixed-day schedules and many field audits? I will prepare detailed, professional audit reports for you. All you need to do is submit your findings attached to the audit checklist, and I will handle the rest.


As a certified ISO 13485 auditor, I understand the full process and can draft your reports accurately for:


Stage 1 audits

Stage 2 audits

CAPA review

Surveillance audit reports

Or any other ISO 13485 compliance documentation


Already drafted a report? I can also review it thoroughly, check for compliance gaps, and refine it for accuracy and clarity.


If youre planning to conduct your first audit but dont yet have an audit checklist or the ISO 13485 standard template, I can prepare these for you at a cost.


Before we engage, we can schedule a 30-minute call to discuss your specific needs and see how best we can work together as regulatory affairs professionals.

Let me save you time, ensure compliance, and deliver clear, auditor-ready ISO 13485 reports

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Conheça mais sobre Amos M Gideon

Amos M Gideon

Biomedical Engineer Medical Devices R and D ISO 13485 LinkedIn Expert

5,0(3)

Level 1

  • A partir deQuênia
  • Membro desdemar. de 2023
  • Responde em aprox.:1 hora
  • Última entrega3 semanas
  • Idiomas

    Inglês, Suaíli
I am Gideon Amos, Biomedical Engineering Technologist , Medical Devices Regulatory Compliance specialist, Biomedical Calibration Engineer & Trainer and ISO 13485 Auditor with a deep passion for advancing medtech innovation across healthcare systems. I hold a certification in ISO 13485: 2016 Quality management systems in medical devices and I understand medical devices regulatory framework. I understand medical device innovation from concept to commercialization and have done projects in R&D ,concept research and design & development review. I have experience in installation, service, preventiv

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