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Compliance Monitoring Articles & Analysis: This-Year
3 articles found
Quality issues in medical devices often point to underlying weaknesses in the system, and ISO 13485-compliant CAPA is essential for correctly identifying cause and preventing the problem from recurring. Here’s an overview of CAPA requirements in ISO 13485 for medical device ...
A nurse works late, spending hours manually logging incident reports instead of caring for patients. A hospital administrator wrestling with scattered spreadsheets, trying to prepare for an audit that’s days away. Sound familiar? These time traps can be difficult to avoid in private healthcare. However, every minute lost to administrative inefficiencies is valuable time lost for ...
Imagine this: it’s 8:30 AM, and your hospital’s leadership team is preparing for a surprise Care Quality Commission (CQC) inspection. Despite weeks of effort, spreadsheets are scattered, incident reports are incomplete, and audit trails are missing links. The anxiety is palpable – because manual systems have left you vulnerable to compliance gaps. This is the reality for ...
