US Medical Device and
Quality System Regulations - Design Controls & Validation
Course Director
Course Fee
$2650.00 Regular Registration
$2450.00 Early Bird Pricing (Register 30 Days in Advance)
Future Livestream Sessions (click to register)
Course Description
This course focuses on introducing the students to the design control requirements for medical devices stipulated under the U.S. Medical Device Quality Systems Regulation. Each of the seven key elements of Design Control compliance will be briefly reviewed. In addition, specific GMP requirements, submission dossier preparation throughout the Design Control life cycle and submission strategy will be discussed.
This course is US-focused. The students will gain a fundamental understanding of how medical devices are regulated in the U.S.: the main legal basis, FFDCA (21 U.S.C. 301), the specific Medical Device Quality Systems Regulation and the comparison/contrast of the GMP requirements imposed on the medical devices and pharmaceutical products in the U.S. In addition, the students will be introduced to a brief overview of relevant global regulatory framework, including the EU MDR 2017/745 and key ISO standards like ISO 13485:2016 and ISO 14971:2019.
There are seven major building blocks for the Design Control of medical devices, outlined by the FDA and based on the Quality System regulation: User needs, Design inputs, Design process, Design outputs, Design verification and validation and Design Review. This course covers all aspects of these seven building blocks for the purpose of providing the students with a clear picture of the entire design control process and corresponding regulatory compliance requirements. Discussion topics are centered on proper translation from the initial user needs to the final design outputs, timing and essential elements of Verification vs. Validation for effective transfer for commercialization. Particular attention is paid to risk considerations and how to properly conduct risk analysis and then manage the risks.
Who Should Attend This U.S. Medical Device Validation and Compliance Course?
This 20-hour course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists and quality engineers needing a comprehensive understanding of U.S. laws governing medical devices and relevant device quality system regulations, in particular, all essential elements of Design Controls, Design Inputs/Outputs, Human Factors, Design Validation/Verification and Risk Management.
The course is especially useful for cross-functional teams that need to align technical development with regulatory and quality requirements. It helps participants understand how design controls, verification, validation, risk management, traceability and design transfer work together. This helps large teams make better decisions, strengthen their documentation and reduce compliance gaps as products move toward commercialization.
FAQs
Related Courses
- Basic GMP Training for the QC Laboratory
- Integration of Risk Management Principles and Activities into the Pharmaceutical Quality System
- Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions
- Medical Device Process Validation Training for Professionals
- Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
- Overview of FDA Regulatory Compliance for Medical Devices
- Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.