Medical Device Regulatory compliance
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Regulatory & Compliance
Medical Device Regulatory compliance
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Regulatory & Compliance
Reduce safety and financial risk with proactive responses to FDA alerts and recalls
Navigating the medical device regulatory compliance environment is critical to protecting both your patients and your organization. Yet disjointed processes for communicating urgent developments like FDA alerts and recalls can leave you unaware of safety risks and susceptible to costly fines.
Patient safety is the chief guiding principle of TRIMEDX’s clinical engineering services, and that includes streamlining corrective actions triggered by FDA alerts and recalls. Through RSQ, TRIMEDX’s computerized maintenance management system, health systems can take advantage of automatic work orders when FDA alerts or recalls impact their devices. This automation reduces response times and cuts down on the manual effort of monitoring alerts and recalls as well as inventory matching.
Our Quality and Medical Device Regulatory Compliance Team Supplements Biomed Teams With:
- Accreditation and regulatory surveys
- FDA alerts and recalls
- Mock audits
- Supplier quality audits
- Environment of Care (EOC) investigations into patient safety incidents
White Paper
Advancing medical device cybersecurity beyond regulatory compliance
The cybersecurity regulatory, standards, and compliance landscape for healthcare organizations has evolved rapidly in recent decades. At the same time, cybersecurity risks are quickly outpacing responsive measures from regulations and medical device manufacturers. Download our white paper to learn how building regulatory standards into a broader framework of risk management can drive a more actionable strategy that both better guarantees compliance and practically protects healthcare technology infrastructure.