Y.M.G. Services
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Overview
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.
Standards & Methodologies
Key QA Services: ? Implementation of quality systems, procedures ? Documentation processes to meet international regulatory requirements. ? Corrective and preventive action programs ? Design control, including risk management and design validation ? Document control systems ? Software quality assurance ? External compliance auditing ? QMS Training ? Define biocompatibility and sterilization tests ? Guidance of safety and EMC tests
Qualifications, 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.
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Testing Types
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