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.
Productivity and efficiency are top priorities for many organizations, as seen from the 2023 Global DevSecOps Report. It is no coincidence these two priorities are also the driving forces of DevOps. Explore how businesses utilized DevOps practices to achieve success...
Whether you are in the tech industry or not, you’ve likely heard the term, Software-as-a-Service (SaaS). SaaS is making a shift from being optional, to essential for many businesses due to the flexibility, security, scalability, and improved collaboration it...
SCOTTS VALLEY, CA - SPK and Associates has been named as one of the world’s top-performing managed service providers in the prestigious 2024 Channel Futures MSP 501 rankings. The Channel Futures MSP 501 list, a technology industry benchmark, ranks companies based on...
Productivity and efficiency are top priorities for many organizations, as seen from the 2023 Global DevSecOps Report. It is no coincidence these two priorities are also the driving forces of DevOps. Explore how businesses utilized DevOps practices to achieve success...
