Venture Zebra Group

Risk Analysis Specific to the Medical Device Industry

Despite evolving practices, preventable injuries and deaths are still prevalent in healthcare. Some of these are attributable to malfunctions or wrong usage of medical devices. Actions that attempt to correct such incidents—as, for example, court settlements, redemptive publicity and product repurposing—are generally more expensive than instituting preemptive measures. VZG specializes in risk analysis, which is an indispensable tool in preventing potential mishaps related to the use of medical devices. VZG consultants are highly skilled in performing risk analysis techniques, particularly, Failure Mode Effects Analysis (FMEA) and Fault Tree Analysis (FTA). 

FMEA is a stepwise approach to the elimination or minimization of a medical device’s potential failures. The outcomes of this type of analysis are recorded in tabular form. It involves the following activities:

  • Naming the functions of the gadget that is being investigated.
  • Determining all possible modes of failure.
  • Narrowing down the potential causes of such failures.
  • Anticipating those failures’ likely effects.
  • Designating a risk index to the identified failure modes.
  • Formulating plans for preventive and corrective measures
  • Monitoring of the plans’ implementation and ensuring their effectiveness.

FTA entails processes that are also employed in FMEA, but the results are presented in diagrammatic form. The steps involved are:

  • Identification of the device’s potential hazards.
  • Determining the possible failures, or combinations thereof, that may lead to such dangers.
  • Creating a fault tree based on the findings.
  • Using the fault tree to define unacceptable consequences.

Risk analyses are best initiated during an apparatus’ designing phase so that appropriate changes can be made early on. They are also generally recommended even after the product has been released in the market to determine possible upgrades. Risk analyses provide manufacturers the following benefits:

  • They ensure the maintenance of high product quality through continuous improvement.
  • They decrease the likelihood of injuries as a result of using the device.
  • They diminish the probability of product recalls and liability lawsuits, thus reducing long-term manufacturing costs.
  • They enable the manufacturer to meet the licensing requirements of various regulatory organizations, such as the US FDA, China’s NMPA and Health Canada.

VZG offers the following services related to risk analysis:

  • Competency training of your staff in performing risk analyses of medical devices
  • Assistance and troubleshooting during the execution of a risk analysis

Why Choose VZG?

Highly Capable Team of Experts

When you allow your staff to learn from the best in the field, they acquire plenty of skills within a short span of time. This will enable you to quickly get ahead of your competitors and secure a bigger market share.

Commitment to Customer Satisfaction

We see to it that all clients who undergo our training programs significantly improve their skills and confidence in handling analytical tasks.

Trustworthiness and Integrity

Risk analysis frequently requires the disclosure of sensitive data. VZG is committed to protecting client information and privacy at all times.