Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls
Russ King, Managing Partner, Methodsense IEC 62304, the international standard [...]
30
04, 2015
28
04, 2015
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]
20
04, 2015
FDA Works to Clarify Device Data Collection Priorities
Michael Causey, Editor & Publisher, eDataIntegrityReport.com A new FDA gui [...]
9
04, 2015
FDA Plays Catch Up In Brave New World of Electronic Consent
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Informed cons [...]
11
03, 2015
Brookings Looks to Advance Medical Device Postmarket Surveillance System
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Patients and [...]
2
03, 2015
FDA Gives MDDS World a Big Break
Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued [...]
4
02, 2015
Training Management Best Practices for Emerging Life Science Companies
Jeff Mazik, Vice President, Life Science Solutions, AssurX No matter how good [...]
14
01, 2015
FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Cen [...]
30
12, 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fisc [...]
19
12, 2014
FDA Update on UDI Implementation for Registered Medical Device Establishments
In case you missed it, the FDA issued this update on UDI yesterday: Having passe [...]
