International and regional regulatory compliance requirements must of course be fully understood and applied from the outset of any new product development. In regulated industries, compliance not only affects the design outcome, but the entire design process.
Applicable regulations for any given product or device are often not clear-cut. For CE-marked products, opinions on harmonised standards may differ significantly between notified bodies, or even between member states within the EU. DC Allen provides clients with access to a dedicated Regulatory Affairs Management group experienced in resolving these types of issues. Additionally, we will work closely with your own Regulatory Affairs department to ensure that the design process and finalised product meets compliance obligations.