Register For Module 1 | Free-To-Attend
Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.
£1,395 Original price was: £1,395.£995Current price is: £995.
The price is for all modules | Register for Online Module – Free
Deep dive into the US FDA medical device requirements to help you build a successful regulatory strategyÂ
Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.
Discount has been applied to the price above. VAT, if applicable, will be added.
Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.
The US device and IVD market is the largest globally and only requires one approval process to access. However, it is important to understand the regulatory landscape, process and requirements to ensure you are successful when submitting an approval. There are many approval routes such as the 510(k), 510(k) exempt, De Novo and premarket approval (PMA) which need to be carefully considered.
This course will provide you with a comprehensive understanding of the regulatory requirements to successfully get your product approved in the US. You will develop an in-depth understanding of how the FDA works and best practices for interacting with the FDA. You will develop knowledge of the various regulatory routes such as the 510(k) to help you construct a regulatory strategy that is speedy and successful. The course will also examine the regulatory activities required post-approval to ensure you maintain your product on the US market and avoid any problems.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver classroom and live online training.
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
4-Day Live Online Training
Register at the top of the page. The largest price saving of £400 will be applied.
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
Pre-course
Action Plan
Reinforcement Session
Recording Available | 60 mins | 1:00 PM (UK)
Overview of US FDA Medical Devices and IVDs
There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
22 September 2025 | 180 mins | 1:00 PM (UK)
Assessing the FDA Regulatory system
23 September 2025 | 180 mins | 1:00 PM (UK)
Regulatory strategies for placing devices to market – part 1
24 September 2025 | 180 mins | 1:00 PM (UK)
Regulatory strategies for placing devices to market – part 2
25 September 2025 | 180 mins | 1:00 PM (UK)
Maintaining and keeping your device on the US market
Kathleen Harris has over 30 years of experience in the Life Science and Pharmaceutical industries including as a regulator (USFDA).  With degrees in Biology, Chemistry, and advanced degrees in Statistical Processes and Emerging Market Economics, she went to work for Bard Pharmaceuticals and Cook Biotech before working for the US Food and Drug Administration. Kathleen has since worked as Sr. Vice President of Regulatory and Quality for large multinational organizations. She started 2Harris consulting in 2014,  offering comprehensive global regulatory strategies, ensuring seamless global product registration, and maintaining stringent quality compliance.  Kathleen is a member of RAPS, ABHI,  CLSI Standards Committee, AAMI, AvaMed and ACDI/VOCA.
Specialities include:
This course is suitable for professionals who work in the Medical Device or IVD industries and either have or are planning to have products in the US.
These include:
Educo Life Sciences –
This is a new course – Reviews will be added after the first delivery!