At Fieldfare we understand that meeting regulatory compliance can be a daunting thought and a task that is not always at the forefront of your mind when trying the get your product to market.
However, by avoiding regulatory requirements it only sets up your company for pain and extra costs further down the line, so by doing this ground work first, you are setting the company and product up for success.
At Fieldfare, we know what is vital to have for compliance and we will help you achieve this in the most efficient way.
Our project will start with getting to know your product and where you want to sell it. From there we will formulate a “regulatory landscape” detailing the path your product will take to get to market.
We have knowledge and experience with the following:
- EU submissions (IVDR and MDR)
- US Submissions (510K/De-Novo/PMA)
We can also provide services to compile Technical File and Design History Files, as well as any ad-hoc advice.
Remediation
Do you already have a product on the market? Are you thinking of registering on another market? Let Fieldfare do the leg work for you and perform gap analysis on existing technical documentation to ensure your product is compliant to new regulations.
