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ISO 13485

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Medical Device Training Courses

Ensuring that products are certified to nationally and internationally recognized standards provides organizations with legitimacy and trust. Investing in training for you and your team demonstrates to customers your in-depth knowledge of how your medical devices work to the highest possible safety strategies.

SGS Academy offers a variety of medical device training courses to help give your products a smooth passage to market. Our course catalog includes professional training in ISO 13485, MDSAP and MDR.

Reach new markets for medical devices

MDR Training

Increase your knowledge and stay up-to-date on the EU Medical Devices Regulation to effectively reach European markets.

EU MDR Roadmap: Guiding Your Compliance Journey

SGS Academy is now offering a comprehensive 5-day training on the courses listed below.

Day 1: Overview of the EU MDR
Day 2: MDR Risk Management: Pre and Post Market
Day 3: MDR Clinical Evaluation
Day 4: MDR Documentation Requirements
Day 5: MDR Post Market Surveillance Requirements

Individual courses are available to book below.

Medical Device Regulation (MDR) Overview of the EU MDR

Designed to equip medical device professionals with essential knowledge, this course covers key aspects of the EU MDR, including regulatory requirements, compliance strategies, and implementation challenges.

This comprehensive program covers both pre- and post-market risk assessment strategies, with a special emphasis on software, artificial intelligence (AI), and cybersecurity considerations.

Medical Device Regulation (MDR) MDR Clinical Evaluation

Designed to equip participants with the knowledge and skills necessary to navigate the complexities of clinical investigation and post-market surveillance lite, this program covers essential concepts, methodologies, and regulatory requirements.

Medical Device Regulations (MDR) MDR Risk Management: Pre and Post Market

Medical Device Regulation (MDR) Documentation Requirements

Delve into the essential documentation requirements mandated by MDR to ensure regulatory compliance and facilitate market access for medical devices.

eLearning: Introduction to the New EU Medical Device Regulation (MDR)

Designed to provide in-depth insights into the regulatory landscape governing post-market surveillance activities, this course equips participants with the knowledge and tools needed to navigate Annex III compliance effectively.

This course will provide participants with an overview of the critical changes in relation to EU Medical Device Regulation, along with the implementation timescales.

Medical Device Regulation (MDR) Post Market Surveillance Requirements

SGS Academy provides consistent, effective, and high-quality training to give employees the skills required by their organizations. Stay up-to-date with the latest industry practices, keep on top of ever-changing technical standards, and comply with current legal and regulatory obligations. The skills and knowledge you will obtain through SGS Academy will help you to transform your people and business.

Why SGS Academy?

Contact us to learn more about our public and private medical device training course offerings or to stay up-to-date with all of our upcoming courses!

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ISO 13485 Training

Ensure your organization is meeting the latest requirements with ISO 13485:2016 training.

ISO 13485:2016 Medical Device Requirements

Learn to perform effective internal audits of the medical device quality management system according to ISO 13485:2016.

ISO 13485:2016 Medical Device Lead Auditor

This course comprises learning sessions and interactive workshops. Participants are expected to have basic knowledge of quality management systems before attending.

ISO 13485:2016 Medical Device Internal Auditor

This course will 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.

MDSAP Training

Learn how to comply with the requirements of Medical Device Single Audit Program (MDSAP).

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.

MDSAP Awareness and Introduction

MDSAP & Regulatory Requirements - Auditor's Perspective

This course provides an essential introduction to MDSAP, ensuring that participants gain a thorough understanding of the program's structure and requirements.