Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles.
When it comes to 483 observations issued for inspections at medical device manufacturing sites, what are the top issues involving Postmarket Activities, specifically Medical Device Reporting?
To answer this question, we ran a Top Issues Report for the period 2017-2022, filtered to show the top issues found by FDA investigators for Postmarket Medical Device Reporting at sites in the United States and European Union.
Here is what we found.
What is the No. 1 Postmarket Medical Device Reporting issue?
Written Medical Device Reporting procedures
What is the No. 2 Postmarket Medical Device Reporting issue?
Manufacturer Reporting Requirements.
To see the rest of the top 20 issues, contact us to request a demo.
As you plan ahead for your next FDA inspection, these are two areas to focus on when it comes to your postmarket activities. FDA has mandatory reporting requirements for medical device issues that occur postmarket.
How Redica Helps Medical Device Manufacturers with Inspection Preparation
Our models show what the FDA is looking for, and the deficiencies it finds—not just at a high level of detail, but at an actionable level of detail.
And our clients can go beyond seeing observations at a macro level. They can trace them back to specific Warning Letters and specific 483s, giving them a great deal of utility when it comes to due diligence. For example, this utility includes gaining insight into their own operational deficiencies and those of company partners and contract organizations.
With Redica, medical device manufacturers can leverage our deeper intelligence about inspection trends and investigator tendencies for thorough inspection preparation.
Strategic inspection preparation based on current inspection findings at your sites and others. Find trends in the data to identify where to focus your attention.
Tactical inspection preparation using complete FDA investigator profiles. What do they tend to look for? What do they tend to find?
Contact us today to learn more about how Redica can help you stay on top of your strategic and tactical inspection preparation.
Additional Resources
Postmarket Medical Device Surveillance at CDRH: Part I
Postmarket Medical Device Surveillance at CDRH: Part II
The EU MDR and Postmarket Surveillance
For information on postmarket activity requirements under the EU Medical Device Regulation (EU MDR), check out the video clip from one of our webinars.
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