Learn how to effectively and efficiently handle the cGMP/ISO document control requirements in this workshop-based program. Click to learn more.
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 U.S., what is needed to complete the 510(k) process, and when a 510(k) must be submitted. Click to learn more.
Are your audits helping your organization meet its strategic goals? Are you looking to acquire skills to make your audit program the catalyst for tangible improvement to your organization’s bottom line? Click to learn more.
Corrective and Preventive Action (CAPA) requirements in FDA-regulated environments can be confusing and difficult to implement. Learn how to not only meet current and future regulations, but also how these regulations can be implemented to be effective and profitable for your company. Click to learn more.
Combine our CAPA Programs for the Medical Device Industry course with our new Root Cause Analysis training for 5 days of intensive training. Click to learn more.
Combine our Risk Management and Analysis for Medical Devices and Design Control Concepts and Implementation courses for an integrated 4-day learning event. Click to learn more.
Learn how to control the design process to assure that your organization's devices meet user needs, intended uses, and specified requirements. 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.
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. Click to learn more.
Understand the requirements and benefits of an ISO 13485-compliant quality management system including steps and timing for a typical implementation. 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.
Based on our ISO 9001 RABQSA-certified QMS lead auditor training course, this interactive course covers ISO 13485 in addition to ISO 9001 requirements for quality management systems. 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.
Designed for both new and experienced professionals in the medical device field, this course will give you a solid understanding of the necessary components of an effective, compliant quality system for medical device manufacturing. Click to learn more.
Get the latest information on risk management concepts and practices for the medical device industry and learn how to plan your organization's risk management and analysis 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.
Learn the fundamentals required to understand how ISO 9001, ISO 13485, and FDA’s Quality System Regulation (QSR) apply to verification and validation of computerized systems. Click to learn more.
Understand the difference between EtO, gamma, and other sterilization methods and their effects on medical devices. 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.