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Serving the Healthcare Industry International Regulatory Consultants (IRC) provides its services to medical device, in-vitro diagnostic, biotech and pharmaceutical manufacturers to help navigate the complex world of regulations. Our primary focus in the regulatory world targets the U.S. Food and Drug Administration and the growing complexities in the international marketplace. Whether you are a startup or a large multinational company you can benefit from the experience and expertise of IRC to meet your objectives in a highly cost effective and often creative way.

From general compliance issues, reporting requirements and product approval submissions IRC has the experience and expertise to help manufacturers navigate the often confusing maze of regulations, policies, guidelines and practices in an ever changing regulatory environment. Our ability to assess issues and provide strategic planning is both unique and effective. In serving your needs we provide value to avoid costly and sometimes irreversible mistakes.

Obelis SA is a European Authorized Representative wihin the EU for manufacturers of medical devices and in-vitro diagnostic products. As required by European Directives companies doing business in the EU who do not have a physical presence or operation within Europe are required to appoint a European Authorized Representative to establish and maintain an "official address" in one of the 25 member countries within the E.U.

MEDLINK EUROPE is a contract service company assisting U.S. medical device companies in sales, marketing and strategic partnering doing business in Europe. They serve as an interim solution linking U.S. operations to European markets until revenues can support an self directed infrastructure. MEDLINK assists in market analysis, product adaptation and strategic pricing, dealer selection, network management and training. MEDLINK headquartered in The Netherlands also maintains offices in Switzerland.

Korea Testing Laboratory, the largest recognized non profit testing laboratory in Korea has provided service to the medical device industry for the past 20 years. It's mission has been focused on helping manufacturers to meet international standards and to obtain certifications such as ISO and IEC. The organization is positioned to help assist with service in regulatory and quality systems matters.

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