OpenAI and Elsmar never trust their help with regulatory questions? Source Cluster: Medical Device Academy Source Node: 2565098Time Stamp: Apr 4, 2023
How quickly will RTA policy take effect for cybersecurity devices? Source Cluster: Medical Device Academy Source Node: 2551298Time Stamp: Mar 29, 2023
Nine easy ways to organize and improve quality system procedures Source Cluster: Medical Device Academy Source Node: 2549310Time Stamp: Mar 28, 2023
Regulatory pathway analysis–a case study Source Cluster: Medical Device Academy Source Node: 2023935Time Stamp: Mar 22, 2023
5 ways to ensure you are a valuable management representative Source Cluster: Medical Device Academy Source Node: 1984060Time Stamp: Feb 28, 2023
How to select and help validate the best sterilization method? Source Cluster: Medical Device Academy Source Node: 1944865Time Stamp: Feb 7, 2023
ISO 19011 – Do you need this quality system auditing standard? Source Cluster: Medical Device Academy Source Node: 1932529Time Stamp: Jan 31, 2023
Software security, what is the best time to test cybersecurity? Source Cluster: Medical Device Academy Source Node: 1917973Time Stamp: Jan 24, 2023
Four easy ways 510k and De Novo content is different Source Cluster: Medical Device Academy Source Node: 1905525Time Stamp: Jan 17, 2023
Why modernize 21 CFR 820 to ISO 13485? Source Cluster: Medical Device Academy Source Node: 1889316Time Stamp: Jan 9, 2023
The best human factors questions in every successful FDA meeting are? Source Cluster: Medical Device Academy Source Node: 1867821Time Stamp: Jan 4, 2023
Software validation documentation for a medical device Source Cluster: Medical Device Academy Source Node: 1777861Time Stamp: Nov 29, 2022
UDI Procedure and UDI Requirements Source Cluster: Medical Device Academy Source Node: 1777863Time Stamp: Nov 17, 2022
ISO 13485 – need training? Source Cluster: Medical Device Academy Source Node: 1786466Time Stamp: Nov 15, 2022
510k Electronic Submission Guidance for FDA 510k Submissions Source Cluster: Medical Device Academy Source Node: 1786468Time Stamp: Nov 8, 2022
Auditing Risk Management Files Source Cluster: Medical Device Academy Source Node: 1788864Time Stamp: Nov 1, 2022
What is an FDA Breakthrough Device Designation? Source Cluster: Medical Device Academy Source Node: 1788866Time Stamp: Oct 25, 2022
How long does it take FDA to review De Novo submissions? Source Cluster: Medical Device Academy Source Node: 1790792Time Stamp: Oct 18, 2022
FDA Registration and Listing for Medical Devices Source Cluster: Medical Device Academy Source Node: 1850100Time Stamp: Aug 26, 2022