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Alternatively, Contact Us if you need more information! We would be happy to speak with you about your specific needs.
Please read our Terms and Conditions before purchasing.
Alternatively, Contact Us if you need more information! We would be happy to speak with you about your specific needs.
Please read our Terms and Conditions before purchasing.
Alternatively, Contact Us if you need more information! We would be happy to speak with you about your specific needs.
One option to get more information about what the FDA may be looking for is to check the 510k database for similar devices that have been subjected to a Freedom of Information request, or FOIA Request.
Looking at the classification order or the reclassification order for device types can give you a lot of insight into the FDA’s thoughts on the benefit risk argument for your device. Addressing the FDA identified risks using the special controls identified for each risk correctly can boost your 510k clearance chances.
We’ve all seen the tree swing analogy. Each member of a project has a different idea about the final product and it results in several misunderstandings.
How could this have been avoided? With good requirements!
Requirements are a contract between the business, the user and the design team. It transforms the user and business needs into a language that guides design, but does not dictate it. It captures all the goals that the design needs to meet in easy to understand language.
510k, De Novo, IDE, PMA, HUD/HDE, Q-Submissions, Standards, Classification.
FDA’s Center for Devices and Radiological Health (CDRH) have published a series of learning modules covering a wide range of topics.
