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Med Safety Board

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Safer products. More receptive clinicians. Effective regulatory submissions.

Safer products. Stronger FDA submissions. Expert guidance.

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.

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

A Proactive Approach to Improving Product Safety

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

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

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.

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“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

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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