We have more than 20 years of experience of consulting services for regulatory and clinical affairs, quality system implementation and maintenance, training and related services, as well as in country representation services, such as European Authorized Representation delivered to the medical device industry. We have delivered quality management systems and certifications for multinational companies such as: Thermo Fisher Scientific, Dako ( part of Agilent), and VWR™ (part of Avantor). Whether you are a manufacturer, importer or distributor of low, medium or high-risk products, we have the expertise to achieve market placement.

CE Marking

We are registered as a European Authorised Representative, certified with the Malta Competition and Consumer Affairs Authority (MCCAA). We are able to assist and meet EU directives and requirements, to achieve the CE Marking, a certification mark that is mandatory for products within the European Economic Area (EEA). We can help insure your product(s) meet EU safety, health, and environmental protection requirements.

Medical Devices & In-Vitro Diagnostic Devices

Meeting requirements for medical device (MD) and In-Vitro Diagnostic Devices (IVD) companies can be difficult, as the approach to regulation varies from country to country. Our compliance team have the experience to navigate MD and IVD compliance in major international markets. We can help identify the regulatory requirements for your device so you can maintain regulatory compliance for devices classified as: Class A,B,C,D (Low, Medium, High). Whether you are a manufacturer, importer or distributor of MD and/or IVD products, we have the expertise to meet healthcare regulatory and safety demands so you achieve market placement.