Manufacturing

Exposure

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Manufactures of medical device and pharmaceuticals are expected to meet all regulatory requirements as set forth by the FDA. The guidance is intended to help manufactures implement quality systems and risk management approaches to ensure safety, efficacy, and complaince. 

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What Can Happen

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If a manufacturer's product does not meet regulatory requirements, the result may be injuries and death related to unsafe products, time-consuming regulator agency reporting procedures, product recalls, litigation, and loss of revenue. 

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Top Recall Regulatory Violations

How to Reduce Risk

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Ensure the company has a comprehensive approach, with well-defined management responsibilities:

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• Quality Control Assurance

  • Quality reporting and management support​

  • Formal and documented quality metrics

  • Compliance with industry standards (e.g. ISO, cGMP, UL, etc.)

  • cGMP compliance and facility sanitation controls

• Sales and Marketing

  • Legal review of products, packaging, inserts, and advertising materials​

  • Standard operating procedures to manage salespersons in a clinical environment

  • Annual training for regulatory, sales, and service/maintenance personnel

  • Standard operating procedures for managing and responding to off-label use

  • Formal and documented customer or end-user training

• Post-Market Surveillance

  • Periodic review of FDA databases and industry new sources (e.g., TPLC, MedWatch, MedSun) for up-to-date information about similar products that have experienced adverse events, Medical Device Recalls (MDRs), and complaints​

  • Compliance with FDA post-market surveillance requirements

  • Crisis management program

  • Product recall standard operating procedures

• Complaint Handling

  • Formal Corrective An Preventative Action (CAPA) program​

  • Protocols for receiving and recording complaints

  • Protocols for escalating complaints to senior management

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Contact us to learn more about how we can help protect your organization.