Regulatory and matching legal affairs are hot topics. And in medical device technology a driving marketing aspect. Setting a adequate legal and regulatory strategy gets rid of the haunting ghost beneath.
Considering the appropriate applicable standards for the product markting plan and concept as well as planning of distinct actions of testing, verification and validation, is specified in Europe by the Medical Device Directive (MDD).
Access to the beneficiary american market is strictly controlled by the US Food and Drug Administration (FDA) authority in Washington. To handle these explicit american FDA requirements, amt cooperates with an experienced and specially skilled US consulting office in the US.