Medical Device Regulation (MDR)(EU) 2017/745 Implementation Training Course

This course is certificated by the Chartered Quality Institute and International Register of Certificated Auditors (CQI/IRCA; Course Certification Number, 2428 - PR 369)Course Criteria - ObjectivesUpon completion of this course, learners will be able to:Explain the purpose of a medical device quality management system (MD QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standard, third-party certification, and the business benefits of the quality management system;Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system  in accordance with ISO 19011 (and ISO 17021 where appropriate);Plan, conduct, report and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.Learners will need to demonstrate acceptable performance in these areas to complete the course successfully.Prior knowledge Before starting this course, learners are expected to have the following prior knowledge:ISO 13485Knowledge of the requirements of ISO 13485, which may be gained by completing a CQI and IRCA Certified MD QMS ISO 13485:2016 Foundation (FD 132) course or equivalent.Medical Device management System AuditThe Plan, Do, Check, Act (PDCA) cycle.The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.Commonly used quality management terms and definitions within ISO 13485 and ISO 9000.The process approach used in MD QMS.A working knowledge of medical device regulatory process applicable to countries the course is designed to cover, including device regulations, regulatory auditing standards and their relationship with ISO 13485.  This knowledge may be gained by successfully completing a CQI and IRCA course relating to individual regulatory authority standards, which will be available subject to demand (e.g. MD QMS Comprehensive EU Medical Device Regulation 2017/745 (EU MRD) Practitioner - PT 219)A working knowledge of risk management principles related to the design of a medical device, for example ISO 14971

This training course allows participants to recognize the technicalities of calibration and metrology, and appreciate the basic ISO 9000 requirements on equipment and instrument calibrations. Registration and Course Introduction Introduction, Fields, Specialist Areas and Types of Metrology Definition and Type of Measurements SI Base and Coherent Units Is Calibration =  Adjustment = Verification ? Reference Standards and Reference Materials Calibration Frequency Elements of an Equipment Calibration System Traceability in Calibration Consideration of Calibration Conditions Typical Measurement Equipment Errors and their Corrections Characteristics of a Calibration Specialist Accuracy, Tolerance, Specification and Deviation Understanding of Full / Partial / Conditional Calibrations Accreditation Scheme – SAC-SINGLAS & ISO17025:2005 Approved Signatory Consideration of Sub-Contracting Jobs About the Endorsed and Non-Endorsed Calibrations Introduction to Measurement Uncertainty – Expanded Uncertainty and Coverage Factor based on SAC-SINGLAS Technical Guide 1, 2nd Edition   Calibration is a protracted work related to maintenance. It must be regularly undertaken on every field instrument in order to ensure smooth functioning and adhere to any regulations. Almost all calibration laboratories' quality systems fulfill the standards set by ISO/IEC 17025:2005, and include all functions that have an impact on the attribute of the 17025 calibration service, like equipment, personnel, calibration procedures and reporting. An integral part of establishing traceability is evaluation of measurement uncertainty.   Metrology (from greek 'metron' (measure), and -logy) is the science of measurement. Metrology includes all theoretical and practical aspects of measurement, including precision calibration and inspection. It can involve cmm or Coordinate Measurement Machines. Traceability is most often obtained by calibration, establishing the relation between the indication of a measuring instrument and the value of a measurement standard.

This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.Join us for an intensive two-day training course that offers a comprehensive deep dive into the Medical Device Single Audit Program (MDSAP) from an auditor’s perspective. This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.During this course, participants will be guided through the intricate details of the MDSAP program, including its grading system, timing, and reporting procedures. The training will cover the step-by-step audit process sequence, providing insights into each stage of the audit. Special emphasis will be placed on auditing techniques based on ISO 19011:2018, preparing attendees to apply these methodologies effectively in their audit practices.Participants will also gain a thorough understanding of the various regulations under the MDSAP program, which encompass multiple jurisdictions including the United States, Canada, Brazil, Japan, and Australia. This course will provide an overview of the specific regulatory requirements of each participating country, ensuring that auditors are well-versed in the diverse regulatory landscapes they may encounter.