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Update: EU Medical Device Regulation Deadlines Extended
European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) raises the bar for device safe [...]
Key Priorities for Proactive EHS Risk Management
In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted over 24,000 inspections, most of them w [...]
FDA Warning Letters Show Document Management System Issues in Food Industry
Documentation is a subject that comes up frequently in U.S. Food and Drug Administration (FDA) warning letters and 483 o [...]
Tips for Preparing for an ISO Certification Audit
Recent ISO data shows a growing number of certificates being issued across all standards. A notable increase is especial [...]
An Overview of the FDA Draft of CSA Guidance for Quality Systems
In September 2022, the (FDA) released draft computer systems assurance (CSA) guidance clarifying software validation req [...]
6 Common Reasons External Quality Audits Fail
In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, an [...]
