
Tag: ISO 13485


FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance

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

FDA Releases New Draft Guidance for Remote Regulatory Assessments

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

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

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

PECB Signs a Partnership Agreement with Isometric Consulting
