Medical Device Regulatory Guide

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Team-NB Position Paper on Hybrid Audits❗️

Key points:

🔹 Hybrid audits are a combination of remote and on-site audits.

🔹 They can be more efficient and cost-effective than traditional on-site audits.

🔹 They can provide a more comprehensive assessment of the manufacturer's compliance.

🔹 There are challenges associated with hybrid audits, including the need for technical expertise and integrating remote and on-site parts.

🔹 The paper discusses the advantages and challenges of hybrid audits and provides recommendations for their use.

 

🔗 Original Document:  https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-HybridAudits-V2-20230516.docx