International Laboratory Directories

Certifications, Accreditations, Licenses:

Regulatory Affairs YMG services provide a full range of regulatory assistance and support to medical device companies. Key Regulatory Services: ? Developing and Implementing Regulatory Strategies ? Determine the optimal regulatory route Preparing and Submitting Regulatory Files such as: ? FDA Pre-market notifications [510(k)s] ? FDA Pre-market approval (PMA) ? Investigational Device Exemption (IDE) applications for the US ,CANADA & Europe ? CE submission ? Technical files for EU marketing ? Canadian device license applications ? Registration of medical device in Israel QA & Compliance Design, assess, and implement quality systems, procedures, and documentation to meet U.S. FDA QSR/GMP, ISO standards, European Medical Device Directives, Canadian Medical Device regulations and other medical device quality requirements. We will guide you in the design, manufacturing and the transfer from design to manufacturing according to the regulatory requirements.

**Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this company.