Rely on the Trusted Authority in Advancing Safety Across Healthcare
Med Safety Board is an Institute for Safe Medication Practices (ISMP) company, powered by ECRI. We leverage over 50 years of experience devoted to preventing medical device, medication-related device, and medication-use errors to achieve positive safety outcomes for our clients. We have exclusive access to the nation's most comprehensive error reporting databases and a team of product safety experts who are licensed clinicians and human factors engineers.
Experience. Expertise. Resources.
Over half a century
of medical device, medication-related device, and medication-use evaluation, safety, and error prevention with ISMP and ECRI.
Exclusive access
to industry-leading ISMP and ECRI error reporting databases and a network of end-user clinicians.
A multidisciplinary team
of product safety experts who are actual clinicians and credentialled human factors engineers.
Challenges We Solve
Limited or no in-house product safety and risk management expertise
Difficulty meeting FDA human factors engineering (HFE) requirements
Insufficient experience with 510(k), PMA, and other regulatory pathways
Lack of insight into regulatory comments and known use-related errors
Barriers to obtaining actionable feedback from end-user clinicians
How We Help
Product Risk Mitigation
A Proactive Approach to Improving Product Safety
Our packaged product risk mitigation solutions assist proactive global medical device, medication-related device, and pharmaceutical companies in addressing safety risks before errors occur and in response to in-market challenges.
Regulatory and Insights Support
Research and Regulatory Support
Our exclusive access to decades of error reporting data results in better-informed product concepts, clinician-intuitive designs, and appropriate medication-use processes. Our end-user clinician advisory board and focus group research capabilities enable manufacturers to obtain feedback from the front lines of healthcare. Our teams support 510k, PMA, NDA, and submissions, in addition to assisting with regulatory body inquiry responses.
Safety Education
We support manufacturer clients with best practices training—including educational programs related to integral product safety processes, human factors engineering, and labeling and packaging—as well as tailored product safety training led by expert clinicians and engineers.
Explore
“Med Safety Board has its finger on the pulse of medication safety. The team’s expertise, combined with open access to ISMP information makes them a part of one of the most highly regarded medication safety entities in the industry."
– Angie Lindsey, Fresenius Kabi
Impact of HFE Studies on 510(k) Success
Does Your Product Have Reported Use Errors or Safety Risks?
Human Factors Engineering
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