- Pre-Sub Meeting Requests
- 510(k) Submissions
- De Novo Applications
- CE Marking
- Canadian Medical Device Licensing
- Device classification
We can also assemble a virtual team to help you with Clinical Studies and FDA PMA Submissions.
View QA/RA Expert Rob Packard’s recording on Regulatory Pathways 101 – Your First Product Launch in Canada, Europe or the USA – CLICK HERE
This is also offered as a standardized service for $1,500. Click here get the details.
View PowerPoint Presentation on SlideShare below or to download click here
CE marking is required for all medical devices sold in Europe. The first step of the process is to determine the risk classification of the device. This is frequently done incorrectly–even by regulatory consultants. Even if you get the classification correct, you then need to select a Notified Body for your medical devices regulatory submission. Rob Packard worked for the world’s largest medical device Notified Body for 3+ years and he has completed dozens of Technical Files and Class III Design Dossiers. Rob is also preparing device manufacturers for the new European Medical Device Regulations.
View Medical Device Academy CE Marking blogs – CLICK HERE
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval (PMA). You should know how to determine the correct FDA regulatory pathway, you should know when you need to request a pre-submission meeting with the FDA and you need to know when your new device should really be submitted as a De Novo Application.
View Medical Device Academy 510(k) blogs – CLICK HERE
The Medical Devices Bureau (Bureau) of the Therapeutic Products Directorate, Health Canada is the Canadian federal regulator responsible for licensing medical devices in accordance with the Food and Drugs Act and Regulations and the Medical Devices Regulations.
View Medical Device Academy Health Canada blogs – CLICK HERE