Software Development
AlterLab Iso13485
Prepares ISO 13485 certification documentation for medical device Quality Management Systems (QMS) — gap analysis of existing documentation, Quality Manuals, required procedures and work instructions, and Medical Device Files. Use for ISO 13485 QMS documentation, conducting a documentation gap analysis, drafting a Quality Manual or SOP/work instruction, assembling a Medical Device File, identifying missing documentation for medical device certification, or when medical device regulations, QMS certification, FDA QMSR, or EU MDR are mentioned. Part of the AlterLab Academic Skills suite.
- Publisher / source
- AlterLab-IEU/AlterLab-Academic-Skills (found on the CSV list)
- Upstream record
- AlterLab-IEU/AlterLab-Academic-Skills
- Version
- Version 2
- Published
- Publication review
- Approved for publication
- Content fingerprint
d2cd140d7817fbc5d2e52f301f0e99732474bab25206c4fea6d22ea5eb1da3ab