Now updated for ISO 13845:2016! This interactive course gives you the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Exercises include audit criteria from ISO 13485:2016. 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.
This course was developed by a leading member of the ISO TC/210 working group responsible for creating ISO 13485:2016. Learn key changes and how they impact your organization.
This on-site only course is for organizations in the medical device supply chain that are considering gaining ISO 13485:2016 certification or are new to ISO 13485 and want to understand the requirements. Click to learn more.
Is your company participating or considering participation in MDSAP? Our 2-day course will help you evaluate the benefits and challenges of participating in the program, and how to plan your transition to the MDSAP program. Click to learn more.
This course covers ISO 14971:2012 (and key distinctions from the 2007 version) and the application of risk management practices throughout a product's full life cycle. Includes coverage of ISO 13485:2016. 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.
Gain a solid understanding of the necessary components of an effective, compliant quality system for medical device manufacturing. Click to learn more.
This course will give your organization the key tools for establishing a robust process for the initial intake and triage of customer complaints and any subsequent global regulatory reporting, whether an individual case (MDR, vigilance report) or a correction/removal to ensure product quality and/or safety. Click to learn more.
Over the past five years, the regulatory bodies have increased their focus on supplier quality programs at companies due to the number of recalls and customer complaints. Click to learn more.
Master the global requirements for medical device development and regulatory submissions, so your company can successfully obtain product approval and gain a competitive advantage in global markets. Click to learn more.
Learn how to control the design process to ensure that your organization’s devices meet user needs. 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.
Corrective and preventive action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement. Learn how to optimize your CAPA Progam to meet requirements and improve your business. 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.
This course will help you master the entire root cause analysis process, from accurately identifying the root cause of a problem to designing an effective intervention. This practical course goes beyond theory to teach you specific steps and tools so you can immediately apply what you learn. Click to learn more.
This practical course will help you understand and interpret applicable calibration requirements and equipment controls for medical device manufacturers, and to understand what compliance means for your organization. Click to learn more.
Learn the fundamentals of software verification and validation, including FDA and ISO 13485 requirements. Click to learn more.
Understand the difference between EtO, gamma, and other sterilization methods and their effects on medical devices. Click to learn more.
Acquire the skills to apply advanced statistical procedures that are relevant to assessing cause-and-effect relationships between multiple process variables, characterizing processes, and improving process performance. Click to learn more.
Acquire the skills to apply intermediate-level statistical procedures that are relevant to assessing process stability, determining process capability, and verifying cause-and-effect relationships between variables that impact process performance. Click to learn more.
Acquire the skills to apply foundational statistical procedures that are relevant to monitoring and measuring process performance.Click to learn more.
Using careful reviews of requirements from ISO 9001, ISO 13485 and QSR along with case studies and in-class activities, learn the fundamentals and principles of process validation. Click to learn more.