December 21, 2022December 22, 2022 stevensevert2

What a QMS Isn’t: Two Common Misconceptions When Implementing a QMS

September 16, 2022December 22, 2022 stevensevert2

FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance

August 20, 2022December 22, 2022 stevensevert2

TC 210 Not Ready to Adopt Definition of Risk Outlined in Annex SL

July 27, 2022December 22, 2022 stevensevert2

FDA Releases New Draft Guidance for Remote Regulatory Assessments

July 21, 2022December 22, 2022 stevensevert2

Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations

July 1, 2022July 27, 2022 stevensevert2

FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing

May 10, 2022July 23, 2022 stevensevert2

After a Global Pandemic, Are Fully Remote QMS Audits Truly Effective?

March 2, 2022July 23, 2022 stevensevert2

PECB Signs a Partnership Agreement with Isometric Consulting

March 2, 2022December 22, 2022 stevensevert2

The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485