Medical Device QMS and GMP Training
NSF’s training courses give you tools to ensure your product complies with international standards and regulations. Our diverse training programs teach you how to implement and apply global guidelines through all stages of the product lifecycle.
Learn more about our quality management systems and GMP training. Whatever your requirements, our expert team has you covered.
Instructor-Led Courses
ISO 14971:2019 - Risk Management for Medical Devices and IVDs - Practical Application
ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls.
ISO 13485:2016 - Fundamentals -Medical Devices - QMS - Requirements for Regulatory Purposes
This instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses.
Preparing for FDA Medical Device Inspections – Practical Guidance
Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection.
Preparing for FDA Medical Device Inspections – The Requirements
Recognizing what to expect during an FDA inspection enables a medical device manufacturer to effectively prepare for the inspection.
ISO 19011:2018 - Applying Principles to Medical Device QMS Audits
This fast-paced instructor-led one-day course covers the basic concepts of planning, conducting, and reporting a medical device quality management system (QMS) audit in accordance with ISO 19011:2018.
ISO 9001:2015 – An Overview and Changes
This ISO 9001:2015 course is available as corporate in-house training and can be delivered in a format and time frame that works for you and your team.
CAPA Considerations: Problem Statement Writing and Investigation Techniques
Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms.
Writing Effective Nonconformity Statements During Medical Device QMS Audits
This virtual instructor-led one-day course will introduce you to the importance of writing effective nonconformity statements during medical device manufacturer quality management systems audits.
This course covers the fundamentals of medical device QMS auditing that influence the writing of effective nonconformity statements; and how to recognize when to communicate nonconformities during an audit; and identify tools and tips for writing effective nonconformity statements.
Online Self-Paced Courses
FDA QMS Regulation 21 CFR Part 820
On 02 February 2024 FDA announced in the Federal Register a final rule amending the device current good manufacturing practices (CGMPs) requirements codified within the Quality System Regulation, 21 CFR Part 820. The amendment has resulted in the Quality Management System Regulation (QMSR). This course provides in-depth insight relative to the content and implementation of the new Quality Management System Regulation.
Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
Our instructors review the requirements of post-market surveillance (Articles 83-86) and post-market vigilance (Articles 87-89), and provide expert advice for manufacturers throughout the course.
U.S. Medical Device Quality System & Combination Products Regulations – Practical Instruction
This course includes six modules. The first five modules cover the U.S. Quality Systems Regulation (21 CFR 820) and the sixth module covers the Combination Products Regulation (21 CFR Part 4).
U.S. FDA Medical Device Reporting Requirements
The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA.
Medical Device Complaint Handling and Servicing
Maintaining proper complaint files is an essential element of the medical device quality management system.
ISO 14971:2019 - Application of Risk Management to Medical Devices Overview
ISO 14971 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls.
ISO 13485: Medical Devices QMS - Requirements for Regulatory Purposes
This two-hour course provides in-depth instruction and expert clarification of ISO 13485:2016, the standard that serves as a basis for many medical device QMS regulations around the globe.
ISO 17025 General Requirements for Testing and Calibration Laboratories
Our two-hour ISO 17025 Testing and Calibration Laboratories course provides the learner with a thorough understanding of the ISO 17025 requirements and what they mean for you and your business as a crucial component of ensuring compliance and quality assurance.
Introduction to Writing Effective Nonconformity Statements During Medical Device Manufacturer QMS Audits
In this approximately 30-minute self-paced course, you will be introduced to the importance of writing effective nonconformity statements during audits of medical device manufacturer quality management systems.
FDA Inspections of Medical Device Manufacturers
In preparation for an FDA inspection, it is important to familiarize yourself with the tools used by FDA investigators to conduct the inspection and to assess inspection outcomes to determine if further FDA action is necessary.
Understanding Top Management Responsibilities for Medical Device Quality Management Systems
Medical device regulators from around the world have recognized the importance of top management’s commitment to quality as essential to establishing and maintaining an effective quality management system.
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Interested in Corporate In-House Training?
Don’t see what your team needs? We can deliver a broad range of medical device QMS and GMP courses in a format that works for you and your team.
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