Project Closed
100 Page Study Report Content QC, April 15-May 1 2023

100 Page Study Report Content QC, April 15-May 1 2023

Study Report QC- Approximately 80 pages of a study report, to be submitted in 510K.  Final draft expected to be available April 15, looking for a QC completion date of May 1.  Report will be provided electronically.  Content QC required- checking study report body content against tables listings and figures.  Formatting QC most likely not […]

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Project Closed
Q-Sub- AI

Q-Sub- AI

Independent consulting experience needed writing/reviewing Q-Sub/Pre-Sub for a device. Product: This is an AI platform which functions as a risk assessment tool for maternal hemorrhage. Timeline: Project would commence In August 2022 and extend over the next ~45days.

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Project Closed

Medical Device Single Audit Program (MDSAP) Needed- Health Canada

I have a friend that needs a consultant with experience in preparing for Medical Device Single Audit Program (MDSAP) specifically for Health Canada and FDA.  They already have a contract/agreement scheduled for a two-phase audit with InterTek Inc. and needs immediate help preparing for it. ·  Medical Device Single Audit Program (MDSAP) specifically for Health […]

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