New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Medical Device Quality & Compliance Learning Path
4.6
★★★★★
97% Recommended
Updated 2025
18 hours
176 active users
18 points
If you'd like to swap a course or add additional courses, Customize Your Bundle — or reach out to us and we'll tailor a learning path to your training needs.
Your Study Basket
1 x Medical Device Quality & Compliance Learning Path
| Total | |
VAT is levied as per your country’s applicable rules and rates at checkout
Each course includes:
Fully compliant
This learning path is aligned with ISO 13485:2016, ISO 14971:2019, FDA 21 CFR Part 820, and UK MDR requirements — providing comprehensive compliance coverage for the topics covered. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam does not mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
The Medical Device Quality & Compliance Learning Path prepares professionals to manage quality systems, risk management, cybersecurity, and regulatory transitions across the medical device lifecycle. It covers software assurance, UK MDR transition, US GMP requirements, ISO 13485 auditing, and device cybersecurity.
Participants will develop the skills to manage medical device quality systems and compliance obligations across UK, EU, and US regulatory frameworks.
Courses Included
Applying computer software assurance principles to medical device production and quality management systems.
3 hours
3 pointsNavigating the UKCA marking process and the transition to UK MDR requirements.
3 hours3 points
Good manufacturing practice requirements for medical devices under FDA 21 CFR Part 820.
2 hours3 points
Applying the ISO 14971:2019 risk management process throughout the medical device lifecycle.
3 hours2 pointsConducting internal audits and preparing for inspections against ISO 13485:2016.
3 hours2 pointsPremarket and postmarket cybersecurity requirements for medical devices under FDA and EU frameworks.
3 hours3 pointsOur Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Frequently Asked Questions
- Medical device QA and regulatory affairs professionals
- QMS internal auditors in medical device organisations
- Professionals managing UK, EU, or US medical device compliance
- Cybersecurity and software assurance specialists in med-tech
Upon completion of this learning path, participants will be able to apply software assurance principles to medical device QMS, manage UKCA/UK MDR transition requirements, apply FDA 21 CFR Part 820 GMP requirements, conduct ISO 13485:2016 internal audits, apply ISO 14971:2019 risk management, and address medical device cybersecurity requirements.
Recommended Courses
Best SellerEssentials of EU MDR
Professional
Best SellerGood Clinical Laboratory Practice (GCLP)
Intermediate
Best SellerICH GCP in English R3
Beginner and Intermediate
Statistical Process Control
Intermediate
