Medical Devices
Pharmalink provide a full range of consulting and contract services for the development and registration of medical devices. Our consultants have vast experience of all aspects of this field and can provide expertise in the registration of Class I, II or III medical devices in the US via the 510k pre-market notification process within the requirements of the Center for Devices and Radiological Health (CDRH).
We also have wide-ranging experience in EU legislation for Active Implantable Medical Devices Directive (90/385/EEC) AIMDD, Medical Devices Directive (93/42/EC) MDD, the general medical devices directive, or the In Vitro Medical Devices Directive (98/79/EC) IVDD.