FDA, EU, Canada, UK, Japan, Australia, etc.
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IVD Consulting Assistance
- In vitro diagnostics (IVDs) are tests done on samples such as blood or tissue that have been taken from the human body.
- The major regulatory bodies all regulate IVDs (FDA, EU, Canada, UK, Japan, Australia, etc.).
- Europe’s regulation is (EU) 2017/746 (IVDR) went into effect in May 2017. After May 26, 2022, new devices will have to meet the requirements of the IVDR to be placed in the European market. Subject to certain conditions, devices currently CE-marked under the IVD Directive (IVDD, 98/79/EC) have until May 25, 2024, to fully comply with the new regulation.
What we do
- Vision28 will write and submit your Q-submission, 510(k), De Novo, or PMA for your IVD to the FDA.
- We will work “hands-on” with you to notify or obtain approval from your European Notified body for your IVD device.
- We will also prepare a global regulatory strategy for registration of your IVD in other markets.
- Vision28 will guide you step by step through the applicable regulations to be able to market your device.
Sheila Ramerman has 30 years’ experience in the medical device industry, and she is especially familiar with IVDs, point of care testing devices, and software. Because her original education and work experience as a hospital lab tech, she understands how IVDs “work” and are used. And, because of her work in R&D for a lab device manufacturer means she understands the IVD development process.
Sheila primarily works with entrepreneurs, start-ups and small companies, whether they are brick-and-mortar or virtual entities. With these companies, Sheila has worked with home-testing, point-of-care, and lab-based IVDs, and both manual and automated test platforms. Analytes include clinical chemistry, hematology, coagulation, and microbiology devices.
More recently, Sheila has worked with diabetes data management and other software products. In the US, she has successfully submitted or worked on numerous pre-IDE/pre-submissions, over 40 Traditional and Special 510(k) submissions, and IVD de novo applications. Worldwide, Sheila has experience with premarket and postmarket requirements in Canada, EU, and Asia-Pacific regions.
Because Sheila has an extensive IVD background, she will make an excellent value added addition to your virtual IVD team.