Category

Healthcare

The latest posts about #Healthcare

CDS Coalition Seeks to Reverse FDA Final Guidance for CDS
Enzyme Team
Mar 14, 2023
10
min read
Data, Standards Emerging for AR/VR Product Development
Enzyme Team
Feb 15, 2023
5
min read
FDA’s Extended Reality Program Seeks Answers to Scientific Questions
Enzyme Team
Feb 7, 2023
5
min read
FDA Deficiency Letters Now Subject to Supervisory Review
Enzyme Team
Nov 21, 2022
5
min read
Review Times Flat Under MDUFA V, and User Fees Up Across the Board
Enzyme Team
Nov 2, 2022
10
min read
ICH Expands on Analytical Methods Validation in Draft- Q2 Update
Enzyme Team
Sep 22, 2022
5
min read
Regulatory Framework Comparison Series: Post Market Devices
Enzyme Team
Jun 1, 2022
5
min read
FDA De Novo Device Program a Tremendous Value
Enzyme Team
Apr 26, 2022
10
min read
Digital Tech for Clinical Trials May Carry Hefty Compliance Requirements
Enzyme Team
Jan 11, 2022
5
min read
FDA, ISO and the Risk Management Quandary
Enzyme Team
Apr 27, 2021
10
min read
FDA Electromagnetic Compatibility Requirements Growing
Enzyme Team
Apr 20, 2021
10
min read
Remote Audits are Gaining Traction in the Era of COVID-19
Enzyme Team
Mar 16, 2021
10
min read
FDA Action Plan for AI an Incremental Step
Enzyme Team
Mar 9, 2021
5
min read
FDA Cybersecurity Communications Likely to be Costly
Enzyme Team
Feb 19, 2021
10
min read
FDA Posts Microneedling Final Guidance
Enzyme Team
Feb 16, 2021
10
min read
CDRH Wraps Up Guidance for Nitinol Devices
Enzyme Team
Feb 12, 2021
5
min read
CDRH Guidance Agenda for FY 2021 Includes CDS Final Guidance
Enzyme Team
Feb 10, 2021
10
min read
FDA Opens Digital Health Center of Excellence
Enzyme Team
Oct 4, 2020
8
min read
Breakthrough Devices May Draw Four Years of Medicare Coverage
Enzyme Team
Sep 22, 2020
9
min read
Enzyme Offers Support for Teams Dealing with COVID-19
Enzyme Team
Mar 19, 2020
5
min read
What Digital Health companies can expect from the FDA in 2020
Ryan Stellar
Oct 17, 2019
2
min read
Expert Interview: Clinical Trial Planning for Startups with Boulder Clinical Science
Ryan Stellar
Oct 15, 2019
5
min read
Farewell, Dr. Gottlieb, you will be missed
Jared Seehafer
Mar 7, 2019
3
min read
FDA Pre-Cert v1.0 Explained: 2019 and the Promises of Years to Come
Manasi Shukla
Jan 9, 2019
7
min read

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