Medical Devices courses

This program is designed to provide attendees with the tools and knowledge necessary to upgrade their quality system to an international recognized medical device standard.In addition to providing the requirement for compliance with the latest standard - ISO 13485:2016, attendees will learn how to prepare, manage and successfully complete an inspection by the certification bodies. COURSE OUTLINE: Personnel attending this program will have an opportunity to learn how to prepare for an ISO 13485 audit, what to expect during interaction with auditors and how to respond to the findings.Additionally, this course provides compressive review on the latest ISO 13485:2016 which including the new requirements in version 2016 and its relationship with ISO 9001:2015.This course is a good refresher for all personnel involved in the medical device business and an opportunity to compare your internal audit system against what a leading internal audit expert believes is the best approach to implement. The course is provided in an informal atmosphere and an easily understood format.  A test will be arranged during the course.PROFESSIONAL TRAINER: Tutor with more than 10 years of working experiences in auditing the medical device and electronic appliance industry. Experiences across R&D, Production Technique, Quality Assurance & Quality Management System. (SGS Hong Kong Ltd. reserves the right of final tutor arrangement.)CERTIFICATION (Attendance: 100%): Delegates who successfully completed the course and passed the test will be issued a certificate by SGS Hong Kong Limited. GENERAL INFORMATION: Venue: T.S.T. / Wan Chai / Sheung Wan Training Centre / HKSTP / TBC Medium: Cantonese supplemented with English materials * Early Bird Price will be offered to participant whose enrolment is made one month prior to the course or online booking

ISO 14971 is unique risk management for medical device industry. It provides a systematic approach for whole process on risk management, for design to post production phases. To demonstrate that we have an established system to eliminate, reduce and manage risks to our medical devices. COURSE OUTLINE:What is Risk? ISO 14971 Standard briefing Relationship between different countries WorkshopsTest PROFESSIONAL TRAINER: Tutor with more than 10 years of working experiences in auditing the medical device and electronic appliance industry. Experiences across R&D, Production Technique, Quality Assurance & Quality Management System. (SGS Hong Kong Ltd. reserves the right of final tutor arrangement.) CERTIFICATION (Attendance: 100%): Delegates who successfully completed the course and passed the test will be issued a certificate by SGS Hong Kong Limited. GENERAL INFORMATION: Venue: T.S.T. / Wan Chai / Sheung Wan Training Centre / HKSTP/ TBC Medium: Cantonese supplemented with English materials * Early Bird Price will be offered to participant whose enrolment is made one month prior to the course or online booking **Discount will be offered to HKMHDIA members

COURSE OUTLINE:Quick review of ISO 13485:2016 versionProcess approachManagement process and supporting process - Quality Management SystemResponsibilities and duties of lead auditor, auditorAudit planning and preparationObjectives collection and analysis of evidenceReview, report and follow-upTestPROFESSIONAL TRAINER: Tutor with more than 10 years of working experiences in auditing the medical device and electronic appliance industry. Experiences across R&D, Production Technique, Quality Assurance & Quality Management System. (SGS Hong Kong Ltd. reserves the right of final tutor arrangement.) CERTIFICATION (Attendance: 80%): Delegates who successfully completed the course and passed the test will be issued a certificate by SGS Hong Kong Limited. GENERAL INFORMATION: Venue: T.S.T. / Wan Chai / Sheung Wan Training Centre / HKSTP / TBC Medium: Cantonese supplemented with English material * Early Bird Price will be offered to participant whose enrolment is made one month prior to the course or online booking Remark: This course doesn’t cover interpretation of ISO 13485:2016 requirements. Delegates who are not familiar with the requirements should attend ISO 13485:2016 Foundation Training Course first.

Training Coupon – HKD 500 Value (Pay Only HKD 400)Purchase this HKD 500 training coupon for just HKD 400 and enjoy access to our premium training programs.Perfect for upgrading your skills, attending workshops, or exploring new learning opportunities.Key Benefits✅ Save 20% instantly on training fees✅ Flexible usage across selected courses✅ Valid for 6 months from purchase dateHow to Purchase?1. Create an account and add the coupon to your cart for checkout.2. An invoice will be provided after purchase.3. The SGS Academy team will contact you and send the e-coupon within 3 working days.How to Use the Coupon?Contact the SGS Academy team by email HK.Academy.Admin@sgs.com with your selected course and class dates.Special denomination gift vouchers are also available!For inquiries, please contact us by email: HK.Academy.Admin@sgs.com or by phone +852 2765 3530.

Training Coupon – HKD 1,000 Value (Pay Only HKD 800)Purchase this HKD 1,000 training coupon for just HKD 800 and enjoy access to our premium training programs.Perfect for upgrading your skills, attending workshops, or exploring new learning opportunities.Key Benefits✅ Save 20% instantly on training fees✅ Flexible usage across selected courses✅ Valid for 6 months from purchase dateHow to Purchase?1. Create an account and add the coupon to your cart for checkout.2. An invoice will be provided after purchase.3. The SGS Academy team will contact you and send the e-coupon within 3 working days.How to Use the Coupon?Contact the SGS Academy team by email HK.Academy.Admin@sgs.com with your selected course and class dates.Special denomination gift vouchers are also available!For inquiries, please contact us by email: HK.Academy.Admin@sgs.com or by phone +852 2765 3530.

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.

Become SGS Academy Top-up Member “S-Learner” (Hong Kong region only)Our “S-Learner” members have exceptional opportunities to receive special discounts on SGS training courses, gain access to exclusive eLearning & workshops, and stay updated with the latest industry trends.Individual MemberAll individuals are welcome. One member account is for one person.Annual Fee: HK$ 500 (Original HK$ 880) (Quota is limited, reserved on a first-come, first-served basis) *Remarks:The discount cannot be used in conjunction with other promotional offers, joint courses with partners and funding schemes.Tailor-made training courses are excluded from this benefit.Selected eLearning courses include ISO 9001, ISO 14001, ISO 45001, ESG, and IT subjects.Terms & ConditionsApplication GuidelinesAcceptance of applications is at the sole discretion of SGS Hong Kong Limited (SGS). By submitting an application, individuals/ organizations agree to comply with all rules and regulations set forth by SGS. Please note that SGS reserves the right to decline any application without the obligation to provide an explanation.The membership is valid for 12 months upon full payment of annual fee is settled.Members are entitled to enjoy all benefits listed above.Members are expected to adhere to all course guidelines and policies, respect the rights and privacy of other members, and maintain a conducive learning environment.Memberships are non-transferable. This means that the membership benefits and privileges cannot be transferred to another individual/ organizations.Membership fees are non-refundable. Once the membership fee has been paid, it cannot be refunded even if the member decides to discontinue their memberships or if their membership is terminated due to a violation of the guidelines.SGS reserves the right to modify these terms and conditions at any time.SGS reserves the right to terminate any membership if a member fails to comply with these terms and conditions.Personal Data Collection and Usage StatementSGS collects and retains personal data from applicants for the purposes of processing course enrolment applications, administering student and member services, conducting research, and compiling statistics.The collected personal data may be utilized by SGS for direct marketing purposes. This includes, but is not limited to, special offers, educational and training programmes, awards and competitions, membership and alumni activities, promotional activities, and other services and events that SGS may organize.Applicants who wish to access and/or correct their personal data can submit their written requests to SGS. We are committed to ensuring the accuracy and security of your personal information.All SGS services are rendered in accordance with the applicable SGS conditions of service available on request and accessible at http://www.sgs.com/terms_and_conditions.htm.