Online Course 
Product Bundle Medical Device Standards, Specifications and Testing
Member: $500.00 Nonmember: $685.00
This five-course series will enable the regulatory affairs professional to understand how standards, specifications, and regulations are developed for medical devices and in vitro diagnostic (IVD) medical devices. The series also covers a general introduction to the essential requirements and key principles for creating an effective testing strategy to gather robust evidence of safety and performance throughout a product's lifecycle using testing, inspection, and certification (TIC) bodies.
The courses highlight the importance of standards, guidance, and specifications in testing strategies, which contribute to regulatory compliance, a high level of protection, and ensuring the device performs as intended.
This content is introductory and requires no prior knowledge or experience, making it accessible to all learners. Basic educational activities are designed to establish foundational knowledge and competence, which will be further developed in practice or advanced activities.
At a Glance
- Target Audience: This program is designed for new regulatory affairs professionals interested in understanding how standards, specifications, and regulations are developed and used in bringing safer medical devices to market.
- Learning Level: Basic
- Total Length of Course: 4 Hours
- RAC Points: 4
- This course was developed in partnership with Element Materials Technology.
Learning Objectives
Upon completion of this course, participants should be able to:
- Develop and implement effective test plans that minimize delays and regulatory hold-ups by identifying and addressing gaps in non-clinical and clinical test data.
- Guide their organization in formulating and executing regulatory and compliance strategies using standards, guidance, specifications, and testing as important tools for safety and conformity assessment.
- Analyze and determine the optimal timing and selection of tests, as well as identify opportunities to leverage existing data to reduce lead times and costs, while mitigating risks to patients and users.
Courses included in this series:
- Introduction to Essential Safety and Performance Principles
- Introduction to Standards, Specifications and Guidance
- Section 1: How Standards and Specifications are Developed and Introduced
- Section 2: International Classification Systems for Standards and Specifications
- Section 3: International Standards, Specifications and Guidance Associated with Testing
- Introduction to the Testing, Inspection and Certification (TIC) Industry and the Use of Test Laboratories
- Section 1: Introduction to the TIC Industry
- Section 2: Accreditation and Quality Assurance of Testing Laboratories
- Section 3: Identifying, Selecting and Qualifying Testing Laboratories
- Introduction to Test Data and How it’s Used as Evidence of Safety and Performance
- Section 1: How Test Data is Used in Regulatory Submissions
- Section 2: How Test Data is Used in Market Authorisation
- Introduction to Developing a Regulatory Compliance Strategy
Enrollment Period: 12 months
Contributing Authors
Nicole Small, Senior MedTech Manager at Element Materials Technology
Nicole is an experienced technical and regulatory professional with a depth and breadth of experience in the testing, safety and regulation of medical devices – a career spanning over 35 years; of which 20 years were at senior level at the MHRA (UK medical devices regulator) leading on significant public safety issues, educational and operational programs.
Nicole is an experienced technical and regulatory professional with a depth and breadth of experience in the testing, safety and regulation of medical devices – a career spanning over 35 years; of which 20 years were at senior level at the MHRA (UK medical devices regulator) leading on significant public safety issues, educational and operational programs.
She also has over 10 years of experience in testing a range of non-active medical devices in an accredited NHS and commercial test laboratory. This included undertaking root cause analysis and developing testing strategies.
James Pink, Senior Director, Medical Technologies at Element Materials Technology
James is a recognized technical expert with over 25 years’ experience in medical technology product safety and market access. James started in medical physics and clinical engineering and progressed a career in R&D, product safety, product liability, regulation and quality assurance - culminating in a 14-year career in consulting on complex and / or novel medical devices and combination products.
James is a recognized technical expert with over 25 years’ experience in medical technology product safety and market access. James started in medical physics and clinical engineering and progressed a career in R&D, product safety, product liability, regulation and quality assurance - culminating in a 14-year career in consulting on complex and / or novel medical devices and combination products.
He has extensive experience in learning and development and working for an EU Notified Body. James is a contributor to several medical device standards committees including ISO13485 and ISO 14971 and various product-related standards. He is also an active researcher in data science and how it can be used to reduce regulatory burden. As senior director at Element focusing on the next generation of software supporting the safety and performance of medical devices is one of his key priorities and is a leading developer of RegNav.
