Risk Assessment

Intellectt knows how quality or compliance crises can significantly impact your business—and we have the experience to manage those crises. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment. While not an all-inclusive list, our Compliance Assurance Assessment services for the Pharmaceutical industry include:

• Review the intended use of the medical device.
• Identify hazards and estimate the probability that harm might occur.
• Estimate the severity of each hazard and evaluate the associated risks.
• Control those risks and monitor the effectiveness of the controls put in place.
• Process Failure Mode Effects Analysis (PFMEA)
• Design Failure Mode Effects Analysis (DFMEA)
• Development of procedures for handling Risk
• Controls Plans
• Action items and deadlines
• Reduce the risk