Medical RA

Medical Devices and Regulatory Approval

It is vitally important that proper regard is paid to following the relevant regulatory affairs when developing a new medical product.  It can be difficult to identify the correct standards and guidance to use, and interpreting and understanding the them can present another level of difficulty.

At Zelemiq we offer just the amount of help and support with this you need.  This can start with helping to identify where your product sits within the regulatory framework, identifying which standards and guidance applies.

If required we can also take on the product design work to take your idea and tern it into reality.  Again we can do as much of this or as little as required, some clients want us to do the entire product, while others only need us for one particular aspect of a design.

We can help you with your verification and validation testing to ensure compliance to the regulations.

Finally  Zelemiq can help you to get you product into production and onto the medical market.  We can guide you through the processes of registering your product and obtaining approvals for CE marking and FDA 510(k) applications.