Quality System Regulations for Medical Devices
DURATION
1 dayCPD
Equivalent to 7 hoursCERTIFICATES
All delegates will receive a certificate on completion.DELIVERY OPTIONS
Learn how to meet the FDA’s requirements for selling medical devices in the USA on this Quality System Regulations for Medical Devices training course.
Interactive workshops and discussions will allow your team to consider together how they may successfully implement methods and ideas learned on this course.
- executives and senior management
- R&D managers/engineers and members of design review teams
- RA/QA managers and management representatives
- members of multi-discipline design teams
- sales and marketing, production, shipping, MIS, purchasing
- FDA requirements and how they might affect an organisation
- implementing the requirements effectively so as not to affect other regulatory requirements
- locating key pieces of information within the appropriate documents (DHF, DMR and DHR)
- review of related standards such as risk analysis and the applicable guidance documents
- the relationship between QSR and the Medical Devices Regulation/In Vitro Diagnostic Medical Regulation (MDR/IVDR) and ISO13485/ISO9001 standards requirements
- regulatory requirements for reporting incident/near incidents (MDR)
- addressing 21 CFR Part 11 Electronic Signature and Records
- adding value to an organisation’s management system
- preparing for an FDA Quality System Inspection Technique (QSIT) type audit
- sources of information and further development
- WELCOME AND INTRODUCTION
- Module 1 Overview of Medical Device Regulation in the EU
- Module 2 The USA’s FDA Approach
- Module 3 Workshop 1: The Company Design Processes
- Module 4 Comparisons – FDA/ISO/MDD
- Module 5 The Requirements of QSR
- Module 6 FDA Inspections and QSIT Audits
- Module 7 QSR Design Controls
- Module 8 Workshop 2: Using QSIT
- Module 9 Device Classification
- Module 10 Pre-Market: PMA and PMN 510 (k)
- CLOSE
- interpret the requirements of QSR and its relationship with MDR/IVDR and ISO 13485/ISO 9001 requirements
- identify the methods for successful implementation of the regulations
- prepare for an FDA QSIT-type audit and add value to an organisation’s management system
Delegates will also be awarded with a certificate of completion in recognition of their new knowledge and skills in QSR for medical devices.
In-company training availability
Receive this course exclusively for your organisation, either in-person at your chosen venue or online in our user-friendly Virtual Classroom.
Enjoy cost-effective flexibility and personalised learning with tailored messaging designed to address your unique business challenges.
In-Person | |
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Delegate numbers | Up to 12 |
Total fees | TBC |
Virtual Classroom | |
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Delegate numbers | Up to 10 |
Total fees | TBC |
What's included
- Delegate certificates of attendance.
- Comprehensive course materials and handouts.
- All tutor expenses and courier fees.
- Free cancellation up to 13 working days before commencement.
For courses held outside the UK or requiring significant adjustments, we will clearly inform you of any additional fees before you book.
Next steps
Find out our availability and enquire about this course by completing the form and our training team will get in touch with you.
Alternatively contact us on 0333 123 9001 or email contact@bywater.co.uk to discuss your requirements.
Enquire
Complete the following form to enquire about this course and our training team will be in touch.
Customer reviews
Environment Agency|18th Jun, 2025
Subsea 7 UK Ltd|16th Jun, 2025
Oxford Brookes University|13th Jun, 2025
Tetra Consulting Ltd|12th Jun, 2025
Royal College Of Psychiatrists|11th Jun, 2025
London Fire Brigade|10th Jun, 2025
Hemsley Fraser Deutschland Gmbh|26th May, 2025
Costain Ltd|14th May, 2025
NHS National Services Scotland|12th May, 2025
Astutis|8th May, 2025
Mitsubishi Power Europe Ltd|30th Apr, 2025
Huntleigh Healthcare|30th Apr, 2025