Case studies
Real FDA problems, solved in days.
Complizen does the analysis in seconds. Then an FDA expert checks every line of it. Here are two clients, what we found, and what we did next. Each page also says where the work stands today.
Ortolog · DKS Ortho
Complizen finds the path
It gives you the FDA path, the full list of what that path needs, and what your documents already cover. This takes seconds, not weeks.
An FDA expert checks it
A person reads every line before you do. We never send you an answer that only a computer has read.
You get clear next steps
Not a long report to decode. A list of what to do, in order, with the time each step takes.
Deficiency letter answered, Q-Sub prepared
FDA sent Ortolog a long list of problems. They had 180 days to reply. We used a small part of that time.
- Answers sent long before FDA's 180-day deadline
- Months earlyAnswers sent long before FDA's 180-day deadline
- For Complizen to turn FDA's letter into a plan
- SecondsFor Complizen to turn FDA's letter into a plan
- To prepare their Q-Sub request
- 3 daysTo prepare their Q-Sub request
After a letter from FDARead the storyRegulatory strategy and testing plan, listed in 4 days
DKS Ortho makes knee implants in India. They wanted to sell in the US. First they needed to know what the testing would cost.
- To a written plan and the full test list
- 4 daysTo a written plan and the full test list
- For Complizen to classify the devices and find the FDA path
- SecondsFor Complizen to classify the devices and find the FDA path
- Testing runs now, at labs we found for them
- In progressTesting runs now, at labs we found for them
Before the first submissionRead the storyBoth started the same way. Someone told us about their device.
Tell us what you make and how far you have got. You get your FDA path, the full list of what a submission needs, and what your documents already cover.
One reply from a reviewer. No card, no sequence.