The course will describe US regulatory procedures as applied to medical technology and compare these to EU systems, enabling students to be capable of advising on entering the US medical technology market.
At a glance
- Please enquire for course dates
- Duration3 days
- LocationCranfield Campus
Course structureThe course will be delivered in the form of a three-day residential workshop including lectures and practical sessions. Accompanying lecture notes, will be supplied and support the course throughout.
What you will learn
On completion of the three-day course delegates should be able to:
- Demonstrate a thorough understanding of US medical technology regulation by describing the principles of the regulatory system
- Devise and plan regulatory strategies to enable launch of medical technology on the US market
- Describe the alternate pathways to the US medical technology market and the associated requirements, differentiating between exempt, pre-market notification clearance and pre-market approval products
- Outline the underlying principles and regulatory processes in the US, covering FDA enforcement powers, medical device reporting, quality system regulations, establishment registrations and device listings.
- Describe the principle differences between the US and EU medical technology regulatory systems.
Topics covered by the course include:
- Introduction to US Food, Drug and Cosmetics Act
- Identify the structure and mission of FDA
- Device Classification
- Pre-market Notification
- Pre-Market Approval
- Establishment Registration
- Device listing
- Quality System Regulation and QSIT
- Medical Device Reporting
- FDA audits and enforcement powers
- Combination Products
- Highlight key differences to the EU system
Upgrade to a professional qualification
Cranfield credits are available for this short course which you can put towards selected Cranfield degrees. Find out more about short course credit points.
Who should attendRegulatory affairs professionals wishing to develop their knowledge of US regulatory procedures as applied to medical technology in comparison to EU systems.
PartnershipsThe course has been developed in partnership with (The Organisation for Professionals in Regulatory Affairs).
SpeakersLectures will be delivered by a number of speakers from industry.
Accommodation is available at Mitchell Hall which is located on campus. All rooms are en-suite and bookings are on a half-board basis from Sunday to Friday. If you would like to book accommodation for this short course at Mitchell Hall, please indicate this on the registration form and we will arrange this for you.
Alternatively, you may wish to make your own arrangements at a nearby hotel.
Location and travel
Cranfield University is situated in Bedfordshire close to the border with Buckinghamshire. The University is located almost midway between the towns of Bedford and Milton Keynes and is conveniently situated between junctions 13 and 14 of the M1.
London Luton, Stansted and Heathrow airports are 30, 90 and 90 minutes respectively by car, offering superb connections to and from just about anywhere in the world.
Read our Professional development (CPD) booking conditions.