Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.
Learn the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Click to learn more.
Learn how to implement EU MDR requirements and pass your Notified Body audits.
Designed for experienced auditors, this intensive class will teach you how to apply MDSAP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.
Understand the basic requirements of FDA’s QSR and ISO 13485:2016 - “QMS 101”. Click to learn more.
Learn what it takes to meet usability requirements of IEC 62366, and understand how they relate to ISO 13485, ISO 14971, EU MDR/IVDR, and FDA.
When designing a new combination product, it’s important to have processes in place to avoid go-to-market difficulties.
For experienced auditors who need to perform internal and supplier audits to the EU IVDR requirements.
Learn how to effectively set up a front room/back room audit approach so you are ready for FDA and NB audits/inspections.
ISO 14971:2019 and and ISO/TR 24971 have been released. Get up to speed on how to keep your risk management process state of the art. Click to learn more.
Get an in-depth review of what is different in ISO 14971:2019 and ISO/TR 24971:2020, and how to update your risk management system to align with the changes. Click to learn more.
Learn how to implement a non-product software validation program for medical devices that meets FDA and ISO 13485 requirements.
Learn all aspects of clinical evaluation from planning to postmarket clinical follow-up so your CERs can withstand Notified Body scrutiny. Click to learn more.
Learn how to audit effectively in a remote context us1/ing Information and Communication Technology. For experienced auditors.
If your company makes connected devices, you know cybersecurity is paramount. Click to learn more.
Learn how to apply US and international regulatory requirements and standards for the design and validation of medical device software. Click to learn more.
This course will provide your organization with the knowledge and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system for your combination product. As part of this course, you will identify recommendations for writing quality agreements with contract manufacturing organizations (CMOs) and auditing.
Learn how to apply ISO 14971:2019 and ICH Q9 risk management from both a combination product focus and a process focus.
This course provides a foundation for understanding the regulatory landscape for software development.
Learn what you need to put in your performance evaluation reports so that your in vitro diagnostic device can enter the EU market.
Make sure your organization's electronic records meet US 21 CFR Part 11 requirements.
Learn how to increase effectiveness and efficiency throughout the complaint-handling process.
Understand how to implement a PMS process aligned with ISO/TR 20416:2020 that meets EU MDR, EU IVDR, and MDSAP requirements.
The process of design control - from establishing and verifying inputs to managing change. Click to learn more.
Learn the elements of an effective CAPA program, and how to identify and solve problems with RC tools.
Receive an overview of combination products and explore the regulatory challenges of a product that combines a medical device with a drug and/or biologic.
This course provides an in-depth look at the software development life cycle, using the IEC 62304:2006 as a basis for the course discussions
Obtain knowledge and practical application experience needed for validating software for use in medical device quality management systems.
Learn key changes between IVDD and IVDR, discusses how to make the transition or implement the regulation, learn best practices for implementation. Click to learn more.
FDA and ISO 13485 both require process validation, but they do not offer much guidance. Get the how-to’s in our updated course Process Validation Principles and Protocols. This class features hands-on workshops to ensure you can transfer what you learn to your workplace.
Best practices and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system. Click to learn more.
Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.
Learn the elements of an effective CAPA program and best practices for optimizing your program. Click to learn more.
How to identify and solve problems with RC tools. Focus is on practice application and creating a problem-solving culture. Click to learn more.
Learn how to identify an appropriate regulatory pathway to obtain product approval or clearance in the United States and/or the European Union (EU). Click to learn more.
Exemplar Global Certified QMS Internal Auditor Training Course. Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. Course exercises feature audit criteria from ISO 13485:2016. Click to learn more.
Learn how to effectively and efficiently handle the cGMP/ISO document control requirements in this workshop-based program. Click to learn more.
Designed for experienced auditors. Course participants learn how to go beyond compliance and analyze the performance-related data needed to improve processes, produce higher-quality devices, and achieve better patient outcomes.
Understand the requirements of FDA's Quality System Regulation. Click to learn more.