Medical Device Recall Management - mock recall planning procedures services

Mock Recall planning, training, and testing guide for medical device, pharma, food and beverage, cosmetics and products. Test your recall readiness.

Cybersecurity Risks: The Future of Medical Device Recalls

In simpler times, the U.S. Food and Drug Administration (FDA) mostly concerned themselves with food and drugs. These days, the proliferation of medical devices means the agency needs a robust technology department that includes both hardware and software. These medical devices, like anything else connected to the internet, come with cybersecurity concerns. Learn Cybersecurity [...]

Cybersecurity Risks: The Future of Medical Device Recalls2022-06-06T20:02:40+00:00

8 Steps to Effective Mock Recall Planning Strategy

What Should Your Medical Device Company Consider When Developing a Mock Recall Planning Strategy Having a developed and tested mock recall plan is critical for medical device companies in the event of an actual product recall. Even if your company has never faced a recall, the complex and dynamic nature [...]

8 Steps to Effective Mock Recall Planning Strategy2022-06-06T20:26:59+00:00

Expedited Medical Device Review Leads to More Recalls

The United States Food and Drug Administration has provided expedited priority review for certain medical devices since 1994. The move is meant to shorten the lead time it takes for patients to access breakthrough devices. However, new research published in JAMA Internal Medicine seems to draw correlations between shorter review times and increased chances [...]

Expedited Medical Device Review Leads to More Recalls2022-06-06T20:03:14+00:00

Why Product Recalls Cost Medical Device Manufacturers $5,000,000 a Day

Researching and developing a medical breakthrough is easy when you compare it to the process of getting approval from the U.S. Food and Drug Administration. The FDA had a long list of requirements to reach and maintain compliance, and it’s not a cheap or easy process. Failing to do so, however, can cost your [...]

Why Product Recalls Cost Medical Device Manufacturers $5,000,000 a Day2022-06-06T20:03:54+00:00