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.
Quality System Regulation is a system to ensure that products are safe, and is applied to FDA-regulated products, including medical devices, in the US. The requirements apply to manufacturers of medical devices who plan to bring products to market.
If you are planning to market medical devices, you will need to ensure they comply with the Food and Drug Administration’s stringent requirements. The tutor will spend the day explaining Quality System Regulations (QSR) for Medical Devices CGMP 21 CFR Part 820 and how its requirements might interact with other standards being applied in your organisation. The tutor will point you to salient points within the regulation and other valuable resources, and explore preparation for an audit.
If you wish to market a device in the EU, you may like to take a look at our 1-day course on
Understanding the European Directive 93/42/EEC concerning Medical Devices.
Bywater runs a comprehensive programme of training around the requirements placed on medical device developers and manufacturers to ensure devices meet standards on safety and usability. These include introductory and more detailed training around auditing, risk analysis, and regional requirements. Our complementary courses focus on a number of standards relevant to medical devices, such as ISO 13485, ISO 14971, Quality Systems Regulations, and BS EN 62366.
We deliver the 1-day Quality System Regulations for Medical Devices training course as a dedicated course for your organisation. This gives you the opportunity to determine where you would like the course to run – at your offices, at another venue, or online. You can also choose a date that is most convenient for you.
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