Medical Devices courses

Please see the ISO 13485:2016 Medical Devices Introduction and Awareness Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.Running a standard or customised course at your premises allows you to shape the message and style of the presentation to suit the culture of your organisation. It is the most convenient and cost-effective solution if you wish to train a number of staff in the same location, or when confidentiality is an issue. Once we have agreed the dates and location for your training course, our experts work with you to identify and evaluate your learning objectives and to customise the course content to ensure they are metContact Details+44 (0) 1276 697777Website: www.sgs.co.uk/trainingschedule Email: ukacademy@sgs.com

This course is certificated by the Chartered Quality Institute and International Register of Certificated Auditors (CQI/IRCA; Course Certification Number, 2428 - PR 369)This course consists of 10 VILT sessions and the final examination.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

MDIAPlease see the ISO 13485:2016 Medical Devices Internal Auditor - Virtual Instructor-Led Training Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognised Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognised by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognised by the Hong Kong Medical Device Control Office.

MD-SVPlease see the Quality Management Systems Software Validation for Medical Devices Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.The objective of this course is to provide learners with the knowledge and skills required to implement an ISO 80002-2 compliant software validation process.SESSION 1:• Requirements of the latest version of ISO 80002-2• Software and hardware included in validation processes• Importance of software validation• Critical thinking and change management• Defining the scope of software validation processSESSION 2:• Developing a software validation plan• Understanding process requirements• Implement, test and deploy software validation• Risk management and risk-based approach• Maintenance of software validation processes• Decommissioning software• Documentation management

MD-CEThe aim of this course is to provide learners with knowledge and interpretive skills necessary to understand and implement the requirements of the new Medical Devices Regulations 2017/745 and Med Dev 2.7.1 Rev 4, Clinical Evaluation in relation to expectations for Clinical Evaluations.Furthermore, learners will have a broader understanding of the changing landscape of regulations related to risk management with an objective of increasing patient safety.

MDR The MDR was published in the EU official Journal on the 5th May 2017, formally coming into force on the 25th May 2017. The MDR becomes fully applicable after a 3-year transition period on 26th May 2020. The MDR is now in its transition phase, at the end of which the current legislation of the Medical Devices Directive 93/42/EEC will be repealed and no longer apply in the EU. In the transition period, a device could be CE Marked under either the current Directive or the new Regulation, dependant on the designation of Notified Bodies to the new Regulation and expiry date of certificates under the Directive. Please see the Medical Device Regulation Implementation Training Course (EU) 2017/745 Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that may apply.

MDRMThis course provides a comprehensive introduction to the key elements of Risk Management for Medical Devices, using the harmonised standard ISO 14971:2019, and aims to give delegates a practical foundation in the relationship between risk management, the regulatory requirements and their Quality System.

MDIA Please see the ISO 13485:2016 Medical Devices Internal Auditor Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply. This course has been prepared by the medical device specialists of SGS and the content approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognised Registrar, UKAS accredited certification body 005, under the FDA Approved Persons Program and is recognised by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognised by the Hong Kong Medical Device Control Office.

MDLACPlease see the ISO 13485:2016 Medical Devices Auditor/ Lead Auditor Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.The aim of this course is to provide students with the knowledge and skills required to perform first, second (including supplier) and third party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011.

MDLACPlease see the ISO 13485:2016 Medical Devices Auditor/ Lead Auditor Training Course Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that might apply.The aim of this course is to provide students with the knowledge and skills required to perform first, second (including supplier) and third party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011.

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.