Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSR
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Price: $225.00 USD  |
Download Showcase your commitment to quality, compliance, safety, and professional excellence by earning a recognized certification of training.Training Program: Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSRTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced eLearning. Immediate access to training materials upon enrollment. Description:  Manufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). The internationally recognized standard specifying requirements that a medical device QMS should meet is ISO 13485:2016 from the International Organization for Standardization. The US Quality Management System Regulation (QMSR) incorporates this standard by reference, and compliance with it is enforced by the US Food and Drug Administration (FDA) from 2 February 2026. This course lays out requirements of ISO 13485:2016 and the QMSR, setting them in the context of good manufacturing practices for medical devices. Take the next step in your professional growth and earn an industry-recognized certification from Biopharma Institute -designed for professionals who want to excel in ensuring the safety and effectiveness of medicinal products. These programs not only give you up-to-date regulatory and compliance insights but also deliver practical skills that employers value. Whether you're enhancing your current role or preparing for a new opportunity, Biopharma Institute certifications are designed to set you apart in the competitive and highly regulated pharmaceutical industry. |
Outline:Quality assurance and the quality management system Manufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). In this session, we set out in general terms what a QMS is and why it is important, and we introduce a standard and a law that lay down requirements for a QMS. Management responsibility Top management is responsible for the development, implementation and maintenance of the QMS. They need to emphasize the importance of meeting customer and regulatory requirements, establish the quality policy, ensure that measurable quality objectives are formulated, conduct management reviews, and ensure the availability of resources. This session states the responsibilities of top management for the QMS. Documentation requirements A QMS is established and maintained through documentation that specifies what is to be done and by records of what has been done. In this session, we identify documentation that is essential to a QMS, and we emphasize the central role of the quality manual and the medical device file. Pre-production processes Product realization refers to all the processes that are implemented to successfully manufacture, deliver, install and service products that satisfy their safety and performance requirements. In this course we devote separate sessions to: pre-production processes, and production and service provision. In this session, we set out requirements for planning, customer communication, design and development, and purchasing, as well as control and monitoring of measurement equipment. Production and service provision In this session, we deal with the requirements that apply to the production of the device, its provision to the customer, and post-delivery activities. Measurement, analysis and improvement Under ISO 13485 and the QMSR, measurement and analysis must be carried out not only to maintain product conformity but also with a view to improving the QMS itself. In this session, we deal with requirements for obtaining feedback, handling complaints, reporting to regulators, auditing, monitoring and measurement of processes and product, control of nonconforming product, analysis of data, and improvement. | Objectives:Who will benefit from this module? This course provides essential learning for all personnel involved in the manufacture of medical devices. Learning objectives:
Level: Introductory/intermediate Audience: This course provides essential learning for all personnel involved in the manufacture of medical devices. Region: Europe, USA, other | |
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| Immediate Course Access: | Login details, instructions, and payment confirmation are emailed immediately upon online enrollment. |
| Self-Paced eLearning: | Enjoy 24/7 access to all course materials and assessments for 12 months. |
| Open Enrollment: | No prerequisites or prior work experience required to start. |
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