Medical Regulatory Affairs

Medical Devices and Regulatory Approval

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

This is particularly the case as we complete the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) for Europe and prepare for the new UK regulatory environment that will come into play following Brexit.

We help you navigate an ever changing regulatory environment

At Zelemiq we offer just the amount of help and support with this you need. 

This starts with helping to identify where your product sits within the regulatory framework and identifying which standards and guidance applies.

If required we can also do the product design work to take your idea and turn it into reality. 

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 and proposed UK CA mark.