Understand the basic requirements of FDA’s QMSR and the relationship with ISO 13485:2016. Click to learn more.
Learn how to implement the new FDA QMSR requirements.
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.
Understand the basic requirements of FDA’s QSR and ISO 13485:2016 - “QMS 101”. Click to learn more.
Learn the elements of an effective CAPA program, and how to identify and solve problems with RC tools.
The process of design control - from establishing and verifying inputs to managing change. Click to learn more.
Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.
Learn how to implement EU MDR requirements and pass your Notified Body audits.
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 how to increase effectiveness and efficiency throughout the complaint-handling process.
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 apply US and international regulatory requirements and standards for the design and validation of medical device software. Click to learn more.
Best practices and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system. 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 Medical Device Process Validation Training: FDA and ISO 13485 Requirements. This class features hands-on workshops to ensure you can transfer what you learn to your workplace.
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.
Learn how to effectively set up a front room/back room audit approach so you are ready for FDA and NB audits/inspections.
Learn how to implement a non-product software validation program for medical devices that meets FDA and ISO 13485 requirements.
Best practices and tools to manage a comprehensive, risk-based, cross-functional supplier quality management system. Click to learn more.
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.
If your company makes connected devices, you know cybersecurity is paramount. Click to learn more.
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.
Understand how to implement a PMS process aligned with ISO/TR 20416:2020 that meets EU MDR, EU IVDR, and MDSAP requirements.
This course provides a foundation for understanding the regulatory landscape for software development.
Receive a foundation for medical device labeling in accordance with US FDA and EU requirements. 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.
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.
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.
In this course, you will obtain the knowledge and practical application experience needed to ensure your devices and regulated IT systems maintain or exceed the high level of quality expected by FDA.
Make sure your organization's electronic records meet US 21 CFR Part 11 requirements.
Do you know how to get your devices approved while avoiding common pitfalls and costly delays? Medical device companies must have FDA 510(k) approval to market products in the United States. Learn the best way to get your approval to market in the US, what is needed to complete the 510(k) process, and when a 510(k) must be submitted. Click to learn more.
Learn how to audit effectively in a remote context us1/ing Information and Communication Technology. For experienced auditors.
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.
This course provides an overview of the requirements of IEC 62366-1:2020, including the relationship with the risk management process.