Regulatory Compliance: Five Best Practices for Medical Device Manufacturers
Businesses Succeed Despite Increasing Regulations with Enterprise Quality Management
HOLMDEL, N.J. – Feb. 18, 2010 – In early 2010, regulations in the medical device industry are already coming under increased scrutiny as product recalls and new research raise concerns about consumer safety. Regulatory authorities are responding on multiple levels, from the FDA’s public meeting on pre-market medical device notification to new investments in medical product safety.
Businesses can proactively address current compliance requirements and prepare for upcoming changes by evaluating their operational processes for enterprise-wide quality management. The following are five best practices Sparta Systems recommends that companies leverage to help get medical device products to the market more quickly and in compliance with current and future regulations:
Supplier quality management: Track and manage global suppliers, monitoring which suppliers consistently offer the highest quality materials, and prioritizing relationships accordingly
Electronic medical device reporting (eMDR): Automate and streamline report submission processes, ensuring efficiency and accuracy of submitted reports and creating a single system-wide standard to achieve compliance with reporting regulations
Change management: Enforce rigorous change control procedures across the enterprise that can track requests, approvals, preauthorization, and implementation, then accurately assess quality-related impacts across the organization
Complaint handling: Integrate a global point of record for tracking and trending of adverse events and notifying authorities of customer complaints
Corrective and preventative action (CAPA) management: Establish processes that can trace manufacturing deviations to their root cause, address deviations quickly, and enforce measures to prevent future product safety issues.
Impending regulations necessitate more effective quality processes in medical device manufacturers’ operations. The most successful businesses will re-evaluate their own processes and systems to ensure they are effectively monitoring their operations at every step of the manufacturing process.
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