Eduardo Uribe
@euribe1962.bsky.social
Biopharmaceutical consultant with over 35 years experience.
Lead dozens of health authority audits with no siting's /483s, inclusive of PAI and “For Cause” audits. Increased EBIDTA by harmonizing and streamlining quality systems, cost reductions.
Lead dozens of health authority audits with no siting's /483s, inclusive of PAI and “For Cause” audits. Increased EBIDTA by harmonizing and streamlining quality systems, cost reductions.
prepare by: Map and document where your quality system diverges between QSR and ISO 13485.Prepare for more rigorous documentation requirements, especially for management review and internal audits. Train your team to understand and "translate" between QSIT and ISO terminology.
April 25, 2025 at 3:59 PM
prepare by: Map and document where your quality system diverges between QSR and ISO 13485.Prepare for more rigorous documentation requirements, especially for management review and internal audits. Train your team to understand and "translate" between QSIT and ISO terminology.
FDA just dropped a bombshell at MedCon 2025.
The Quality System Inspection Technique (QSIT) - that trusted roadmap for FDA inspections since 1999 - will be retired completely.
Instead, inspection processes aligned with ISO 13485:2016 will be described solely in the Medical Device Compliance Program.
The Quality System Inspection Technique (QSIT) - that trusted roadmap for FDA inspections since 1999 - will be retired completely.
Instead, inspection processes aligned with ISO 13485:2016 will be described solely in the Medical Device Compliance Program.
April 25, 2025 at 3:57 PM
FDA just dropped a bombshell at MedCon 2025.
The Quality System Inspection Technique (QSIT) - that trusted roadmap for FDA inspections since 1999 - will be retired completely.
Instead, inspection processes aligned with ISO 13485:2016 will be described solely in the Medical Device Compliance Program.
The Quality System Inspection Technique (QSIT) - that trusted roadmap for FDA inspections since 1999 - will be retired completely.
Instead, inspection processes aligned with ISO 13485:2016 will be described solely in the Medical Device Compliance Program.
I have all the CFRs and will travel
April 8, 2025 at 7:31 PM
I have all the CFRs and will travel