Description:YMG services is a professional, experienced, consulting group focused on the medical device industry. Our services include advice on international global Regulatory affairs, Clinical research and global Quality Assurance (QA) for the medical device and cosmetics industries. Our experienced team consists of experts in Pre Market regulatory submissions, facility inspections, clinical trials design and management. Our familiarity with the regulatory process will help you to bring your product to the market much faster.
Y.M.G. Services Itar-Sagi St. , 3/11
Netanya, , 42758 Israel
Products and Services: Clinical Studies YMG provides a range of clinical study services. We have vast experience in designing clinical studies in compliance with regulatory requirements. We manage, design, implement and conduct clinical trials, feasibility , site selection and monitoring. Key Clinical Services: Protocol and CRF design Ethics Committee & Competent Authority Regulatory Submissions Clinical Study Monitoring Site Support Project Management Clinical Quality Assurance Audits Co-source CRA, SSC and CTA Preparation of clinical reports
Experience: **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 .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.