Regulatory

Keep Your Worldwide Product Sales Alive and Well!

Conforming to medical device regulations is critical to the successful marketing of medical products. Ensure your company's conformance to current and new regulations.

McLean Medical and Scientific, Inc., offers . . .

Compliance Consulting:

• Medical Device Directive (MDD)


• In Vitro Diagnostic Directive (IVDD)


• U.S. Food & Drug Administration (FDA)


• 510(k) Devices


• Pre-Market Amendment (PMA) Devices


• Investigative Device Exemption (IDE) Devices


• Audit Assistance with FDA

Services:

• US Agent (FDA)

• Authorized Representative