Live Webinar: Drafting of the Biocompatibility report in accordance with ISO 10993-1 – 15 SEP 17 Duration: 50 min. + 10 min. Questions Time. Register Now! Download the Course Brochure   Description: ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based […]

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Regulation 745/2017 on Medical Devices: Obligations of the economic operators, from Eudamed registration to Responsible person Prerequisite: basic knowledge of medical devices and regulatory requirements in Europe Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Importers Distributors of medical devices in Europe and their suppliers Contents: definition of manufacturer, authorized representative, importer, distributor; […]

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Regulation 745/2017 on Medical Devices: main changes and timeline to implementation Duration: 1 hour Prerequisite: basic knowledge of medical devices Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers Contents: The Commission position on medical devices; regulation implementation timeline, main impacts on existing devices, main […]

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The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes the main methods for writing an Evaluation Report of the Clinical Evaluation to be included in the product Technical dossier according to the new MEDDEV 2.7.1 guideline Rev June 2016. […]

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DESCRIPTION Complaint handling is one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may […]

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DESCRIPTION Complaint handling is one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may […]

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DESCRIPTION Complaint handling is one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may […]

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DESCRIPTION Complaint handling is one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may […]

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How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation   Register Now!     Description: Areas Covered in the seminar Documents Used by FDA Inspectors Operations Manual (IOM) CAPA Implications, by Section Requirements Recommended Methods of Compliance for Each Requirement CPG Manual 7382.845 CAPA Implications, by Section Requirements Recommended Methods of […]

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