ISO 13485 Quality System Templates

All the templates needed to implement an ISO 13485 Quality Management System. Achieve a Quality System that meets the requirements of the US FDA, Health Canada, EU MDR, and more.

Digital file•1 file•By Jeremy Moore

Overview of Software as a Medical Device - Quality Systems and Regulatory Compliance

In this course, we will dive into the fascinating world of software that is designed to be used for medical purposes. Software as A Medical Device (SaMD) is becoming increasingly prevalent in modern healthcare, offering innovative solutions for diagnosis, treatment, and monitoring of various medical conditions. Throughout this course, we will explore the key concepts, regulations, and quality systems that govern the development and maintenance of SaMD. By the end of this course, you will have a comprehensive understanding of how to ensure the quality and regulatory compliance of SaMD products.

Course•By Jeremy Moore

Quality Management Implementation and Support

Coaching•By Jeremy Moore

Quality Manual for ISO 13485

Free download of our Quality Manual developed exclusively for Medical Device startups.

Digital file•1 file•By Jeremy Moore