Homepage
Open in app
Sign in
Get started
Methodology
Pre-Cert Program
DTX
Observations
Technology
Advanced Practice
Workplace
Pre-Cert Program
Deployment of Next-Generation Medical Software Development System in Compliance with New FDA…
Deployment of Next-Generation Medical Software Development System in Compliance with New FDA…
The core concept of the Pre-cert Program and AI/ML Framework is still based on the basic principles of medical device regulations, which…
Vance Chang
Apr 16, 2023
Exploring the Differences Between the AI/ML Framework and the Pre-Cert Program
Exploring the Differences Between the AI/ML Framework and the Pre-Cert Program
The AI/ML Framework and Pre-Cert Program can be seen as the next generation of FDA regulatory requirements. This article uses a holographic…
Vance Chang
Apr 16, 2023
Quick-guide on Software Pre-Cert Program (1) - Freiheit als Autonomie as an essence
Quick-guide on Software Pre-Cert Program (1) - Freiheit als Autonomie as an essence
Series of studies will be conducted on “The Software Precertification Pilot Program version 1.0 Working Model”, released by FDA, and will…
Vance Chang
Nov 2, 2021
Quick-guide on Software Pre-Cert Program (6) — Summary
Quick-guide on Software Pre-Cert Program (6) — Summary
In this article, the author summarized the Pre-Cert Program in the form of the requirements in the four components. It can be considered…
Vance Chang
Dec 14, 2021
Quick-guide on Software Pre-Cert Program (2) — Excellence Appraisal
Quick-guide on Software Pre-Cert Program (2) — Excellence Appraisal
Organizations that produce safer and more effective device software products not only “do the right things,” but they also “do the things…
Vance Chang
Nov 8, 2021
Quick-guide on Software Pre-Cert Program (3) — Review Pathway Determination
Quick-guide on Software Pre-Cert Program (3) — Review Pathway Determination
SaMD products included in the Pre-Cert Program will be reviewed via risk-based approach such as IMDRF framework. IMDRF framework is based…
Vance Chang
Nov 15, 2021
Quick-guide on Software Pre-Cert Program (4) — Streamlined Review
Quick-guide on Software Pre-Cert Program (4) — Streamlined Review
The principal objectives of establishing the streamlined premarket review process component of the Software Pre-Cert Program are to…
Vance Chang
Nov 21, 2021
Quick-guide on Software Pre-Cert Program (5) — Real World Performance
Quick-guide on Software Pre-Cert Program (5) — Real World Performance
During the Excellence Appraisal, all organizations would demonstrate the capability to collect and analyze post-launch Real World…
Vance Chang
Nov 27, 2021
About Medical Device Practitioner’s note
Latest Stories
Archive
About Medium
Terms
Privacy
Teams