Initiation of Risk Assessments

by | May 2, 2022 | Compliance, Consulting Group, FDA, Quality, Risk Management, Standardization, Standards

Risk Assessments are a powerful tool used to elevate regulatory decisions and product changes. Risk assessments are analyzed iteratively to refine the assessment questions, data, and assumptions. Information is exchanged between the risk assessment team and stakeholders within the industry; communication, participation, and collaboration are encouraged in the risk assessment process. A risk assessment provides information on the characteristics of the risk attributed to a hazard.

Device needs, resources, and public health concerns are major considerations in the determination of a risk assessment. The best method for initiation of a risk analysis process includes:

  • Establishing a procedure
  • Develop criteria to evaluate the quality of data
  • Develop guidelines to evaluate
  • Formalize a review process
  • Increase capacity to conduct risk assessments1

Risk management and risk communications are the other key factors in the risk assessment process. Risk management activities are to control the hazards involved in the process. Risk communication incorporates the exchange of information and opinions about the risks. Most risk assessments are iterative, transparent, team-oriented, and collaborative and should be applied to all risk analysis steps1. During the risk assessment process research is usually conducted to discover missing information on the risk mitigation.

The risk management team assembles the appropriate data to draft the technical and interpretive risk assessment summary documents. Depending on the intensity of the risk assessment, the Food and Drug Administration (FDA) staff or other agencies may review summary documents, as necessary. If your company needs assistance with the initiation of a risk assessment EMMA International can assist. Contact us by phone at 248-987-4497 or by email at


1FDA (March 2018). Initiation and conduct all major risk assessments within risk analysis framework Retrieved on APR 25, 2022 from

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

More Resources

The End of the COVID-19 Public Health Emergency

The End of the COVID-19 Public Health Emergency

After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.
Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.

Ready to learn more about working with us?

Pin It on Pinterest

Share This