This session covers all topics and content needed for you to become an Exemplar Global Certified Lead Auditor for ISO 13485. It is a highly interactive session with ample hands on practice on how to conduct audits, write NCs, create audit reports, auditing, facing an audit, and more…

Testing as required by Exemplar Global is conducted and participant engagement during the course is also monitored. A must do if you intend to conduct audits with authenticity, and / or work for a notified body.

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This session covers key topics and content needed for you to become an Internal Auditor for ISO 13485. It is a highly interactive session with ample hands on practice on how to conduct audits, write NCs, create audit reports, auditing, facing an audit, and more.

Testing is conducted to gage learning and ensure participant engagement during the course. A must do if you intend to conduct internal audits with authenticity, and help your company do better in ISO 13485 compliance.

Click here to learn more and for upcoming course dates and locations.

This ISO 13485 Executive Overview Training addresses how management systems (MS) conforming to ISO 13485 apply to the medical device industry and how to use the system to ensure customer requirements are determined and consistently fulfilled over time.

This ISO 13485 Executive Overview Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management.

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Numerous countries have indicated they require ISO 13485 Certification before you can sell products in their jurisdiction; additionally, some have also stipulated that you meet the requirement laid down in MDSAP. QSR / 21 CFR 820 topics are covered as well.

• As a business leader / manager – how do you decide the road map to ISO 13485?
• What are the essentials you need to keep in mind?
• How do you organize your company to accomplish this?
• What milestones do you need to cross?
• What are the frequent tripping points for managers and leaders on this journey, and how to avoid them?

Get answers to these questions and many others. Contact us to request further details on this course.

This session covers the key road map, the milestones, the measures of success for each milestone, and KPIs you can put in place as you embark on the journey of ISO 13485 certification at your company. MDSAP topics are included, so is coverage of 21 CFR 820.

Also included are tips on dialog with Notified Bodies, and preparations for facing the audit.

Contact us to request further details on this course.

Specifically oriented to the design professionals, this session covers key topics and content needed for you to be in compliance with the design requirements as covered in Section 7.3 – Design and Development, together with the requirements of 21 CFR 820, and MDSAP.

Also covered are interconnects between design and: manufacturing, purchasing / suppliers, production, and how Risk Management needs to be integrated.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.

Specifically designed for manufacturing professionals, this session covers key topics and content needed for you to be in compliance with the requirements as covered in Section 7.5 – Production and Service provision, together with the requirements of 21 CFR 820, and MDSAP.

Also covered are interconnects between manufacturing and: design, purchasing / suppliers, production, and how Risk Management needs to be integrated.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.

Specifically designed for managers / supervisors – regardless of their work area (manufacturing, services, etc.) this session covers key topics and content needed for you to be in compliance with the requirements as covered in Section 5 – Management responsibility, and Section 6 – Resource Management, together with the requirements of 21 CFR 820, and MDSAP.

Also covered are interconnects between: manufacturing, design, purchasing / suppliers, production, measurement, analysis, improvement, and how Risk Management needs to be integrated.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.

Specifically designed for “”all”” employees regardless of their work area (manufacturing, services, inspection, customer complaints, etc.) this session covers key topics and content needed for you to be in compliance with the requirements as covered in Section 4.2 – Documentation Requirements, together with the requirements of 21 CFR 820, and MDSAP.

Also covered are interconnects between: manufacturing, design, purchasing / suppliers, production, measurement, analysis, improvement, and how Risk Management needs to be integrated.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.

Specifically designed for sales and marketing professionals this session covers key topics and content needed for you to be in compliance with the requirements as covered in Section 4.2 – Documentation Requirements plus other relevant topics covering nonconforming product post delivery, complaints, labeling / literature / collateral, together with the requirements of 21 CFR 820, and MDSAP.

Also covered are interconnects between: design, services, measurement, analysis, improvement, and how Risk Management needs to be integrated.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.

Specifically designed for all staff dealing with nonconformance this session covers key topics and content needed for you to be in compliance with the requirements as covered in Section 4.2 – Documentation Requirements, 8.3.2, 8.3.3 – Nonconforming product, 8.5.2, 8.5.3 – Corrective and Preventive Action, together with the requirements of 21 CFR 820, and MDSAP.

Also covered are interconnects with other functions within an organization, and how Risk Management needs to be integrated.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.