fbpx
1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

A Review of FDA 483 Observations – Top Med Device Issues Sited & Proper Response

The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.

We invite you to download our paper on the topic of 483 Observations.

Latest White Papers

Excellence in Automotive Software Engineering eBook

Excellence in Automotive Software Engineering eBook

ALM tooling, when implemented correctly, can support automotive software engineering, Agile transformation journeys and linking requirements to business strategy, encouraging collaboration. Additionally, it can be helpful for providing an overview of QA and testing...

Related Resources

Excellence in Automotive Software Engineering eBook

Excellence in Automotive Software Engineering eBook

ALM tooling, when implemented correctly, can support automotive software engineering, Agile transformation journeys and linking requirements to business strategy, encouraging collaboration. Additionally, it can be helpful for providing an overview of QA and testing...

Shifting from FDA 21 CFR Part 820 to ISO 13485

Shifting from FDA 21 CFR Part 820 to ISO 13485

In this Vlog, Chris McHale, Co-founder, and CEO of SPK and Associates is joined by Carlos Almeida, Vice President of Engineering. Together, they’re discussing FDA compliance and the recent shifts impacting medical device companies. Topics for discussion include...

Design Controls Best Practices for Medical Device Companies

Design Controls Best Practices for Medical Device Companies

Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....