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September 16, 2022December 22, 2022 stevensevert2 FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance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July 27, 2022December 22, 2022 stevensevert2 FDA Releases New Draft Guidance for Remote Regulatory Assessments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