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Workexperieince Technical Areas where expertise can be provided
Auditor Requirements: Checked at initial hiring
1. Education:
Auditors must have knowledge equivalent to post-secondary education (typically 4 years) or related work experience.
Relevant fields can include biology, microbiology, chemistry, biochemistry, computer/software technology, engineering, human physiology, medicine, pharmacy, physics, or biophysics.
2. Work Experience:
Auditors must have at least four years of full-time experience in medical devices or related areas, such as healthcare, medical device manufacturing, auditing, or research in this field.
Long Onboarding Technical Areas.xlsxLong form Expertise
Long form Expertise
Details on Pontial MD codes are provided at MDCG 2019-14 health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf
Technical Areas Guidance + Link to MDx codes
Technical Areas Guidance + Link to MDx codes
Please Provide the Technical Areas you have Expertise and indicated
Medical Devices Technical Areas Outline – IAF MD9:2023 Issue 5
Expertise
Responsibilities with respect to design, manufacture, testing or use of device or technologies or experience in a conformity assessment body (please indicate the codes involved in each task)
from - to indicated period when obtained expertise
Employer
Department / Position
health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf
IAF_MD9_Issue_5_20112023 Drive version.pdfThe certifications or qualifications required for each certification function in the context of EU MDR, ISO 13485, ISO 17021, ISO 19011, and IAF requirements need to be in control. These qualifications ensure auditors and certification professionals have the necessary expertise and credentials to certify Class I medical devices effectively.
MD9 Guidance is public. and shared for Reference on this website
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