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Medical Device Risk Management

Identify and Assess Your Risk Hazards

How does your company know what it knows? Is your company able to make a thorough assessment? What did you miss? These are all questions your company should address regarding medical device risk management.

As a medical device manufacturer, you can only afford smart risks. Doing what requires having — or acquiring — the ability to identify risks at every stage of your process is your company’s goal. Your company also needs capabilities for estimating and evaluating those risks. Finally, your company should be meticulously monitoring the effectiveness of your risk management strategy. Failing this strategy puts your entire operation at risk. Medical Engineering Consultants are experts in ISO 14971:2009 Risk Management services and solutions. Here’s how MEC can help limit your risks:

  • You Can Reduce Risk, But You Can’t Eliminate It:
    Risk Management should apply to every phase of your medical device’s lifecycle. MEC has the expertise to collaborate with your top management and establish risk management policies that work to protect your timelines and your products.

  • How Much Risk Can You Handle?:
    Your risk management policies need to reflect what your company defines as acceptable risk. Having an MEC risk management specialist on call ensures that you never take on more risk than planned.

  • Control Your Risk:
    Controlling risk puts you in the driver’s seat. Capture that control with Risk Reviews that evaluate the effectiveness of your risk management strategy at pre-determined intervals and MEC training programs focused on achieving compliance for all standards.

Why risk any more than you have to at any time? Contact MEC.

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