Medical Devices courses

The purpose of this course is to equip learners with a general overview and understanding of the requirements of ISO/IEC 17025:2017.

The course aims to impart the skills and knowledge in conducting internal audits against GDPMDS and the relevant guidance documents.

This 1-day course is designed primarily to provide participants with the knowledge of GDPMDS standard requirement. The delegates will also understand the key requirements in SS 620:2016 (2021) and reference to relevant regulatory guidance documents. Key changes from previous GDPMDS (TS-01) standard would also be highlighted.

This 3-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the new ISO 13485:2016 standard including risk management. In addition, upon successful completion of the course, participants will: Be able to effectively plan, prepare and carry out an internal audit as per ISO 13485:2016 Be able to evaluate the significance of audit findings, develop and implement corrective action programs Have the means to effect greater improvements on their quality systems   Course Content Introduction to ISO 13485:2016 ISO 13485:2016 Overview 1) Section 4: Quality Management System 2) Section 5: Management Responsibilities 3) Section 6: Resources Management 4) Section 7: Product Realization 5) Section 8: Measurement, Analysis and Improvement Auditing ISO 13485:2016 Audit Performances and Audit Reporting Corrective Action

This 1-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the ISO 13485:2016.   The key topics include: Introduction to ISO 13485:2016 ISO 13485:2016 Overview 1) Section 4: Quality Management System 2) Section 5: Management Responsibilities 3) Section 6: Resources Management 4) Section 7: Product Realization 5) Section 8: Measurement, Analysis and Improvement    

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.

An effective risk management strategy is always evolving to meet global standards and requirements. for medical device manufacturers, this has meant developing a strategy that complies with both ISO 13485:2003 and the European Medical Device Directives. Risk Management includes all phases of risk: Risk Analysis, Risk Evaluation, Risk Control and Post Production Information. Proper risk management requires an organized approach to provide a road map for assessing, assigning and reducing risk through the life of the device. The first step is the development of a risk plan that identifies the intended medical use of the device and addresses the risks at each phase of the life cycle of the product. Management needs to assign responsibilites to develop and carry out the risk to qualified personnel. A Risk Management File documents the risk management process through records and other documents. You may include records as part of the file or reference records by the file. You will need to update the Risk Management File as you receive new information through the life of the product or the product family.    

The aim of this course is to provide learners with knowledge and understanding of the additional requirements within the Medical Device Regulation (MDR) as well as of the current directives (MDD 93/42/EE) and ISO 13485:2016, including the terminology used and the certification requirements.COURSE CRITERIAUPON COMPLETION OF THIS COURSE, LEARNERS WILL BE ABLE TO:Identify the links between ISO 13485:2016 (QMS) and MDR EU/2017/745;Explain how terminology has changed and where gaps require additional work for Clients to meet the new requirements;Define new requirements for proactive post-market surveillance;Outline the stages of the transition from MDD to MDR so that clients can create individual transition plans;Define the key deliverables for all economic operators.Learners will need to demonstrate acceptable performance in these areas in order to complete the course successfully.PRIOR KNOWLEDGEBefore starting this course, Learners must have a good understanding of the:Current Medical Directives;ISO 13485:2016;Terminology used; andRequirements to achieve certification.

This intensive course is designed to provide participants with an in-depth understanding of the ISO 13485:2016 standard, focusing on the requirements for a medical device quality management system and the skills needed to lead audit teams effectively. The course combines comprehensive theoretical knowledge with practical auditing exercises, role-playing, and group discussions to ensure participants are well-equipped to conduct and lead internal and external audits.SGS North America is certified by Exemplar Global as a training provider. Participants who successfully complete this course and achieve Competency through the course exam will receive a Certificate of Attainment for the following Exemplar Global knowledge competency unit:MD - Medical Devices Quality Management SystemsAU – Auditing Management SystemsTL – Leading Management Systems Audit TeamsImportant Notes:We recommend that you turn your camera on during the course to enhance engagement and participation.For the course exam, all learners are required to keep their camera on for the entire duration of the exam.Please bring a valid photo ID (e.g., driver’s license, passport, or work badge) to class for identity verification purposes prior to the exam.Enrollment and attendance in this course indicate participant agreement for SGS Academy NAM to share enrollment information (e.g., participant name, email address, Competency Units attempted, TPECS examination results, etc.) with Exemplar Global. This information will not be shared with any third party (e.g., employer) without the participant’s written consent, unless required by law.