Medical Devices Training (ISO 13485)

Medical Devices Management Training (ISO 13485)

ISO 13485:2016 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonised medical device regulatory requirements.

Our Medical Devices Quality training courses are designed to help you:

• Put quality control measures in place

• Identify and manage risks

• Comply with relevant legal regulations

• Manage traceability and recall

• Improve organisational processes

• Improve products

• Increase operational efficiency

NQA is also a proud CQI and IRCA Approved Training Partner, and you can find many CQI and IRCA certified courses within our portfolio.

Why Choose ISO 13485 Training?

Book a place on one of our ISO 13485 Medical Devices training courses where you will be tutored by an industry expert who will help you to improve your skills and understand the clauses within a Medical Devices Management System, how to implement and audit the standard and how to ensure that protecting the integrity of your manufactured products is an integral part of your internal processes.

This training allows companies to reduce safety and legal risks while creating more economical work environments. As an internationally recognised standard of quality and safety for medical device manufacturing, having ISO 13485 certification helps companies get recognised as more reputable, trustworthy providers. The most recent version of ISO 13485 is reviewed every five years and revised according to the new requirements and needs of the industry.

Statistics straight from the most recent ISO Survey have shown a 33.1% increase in worldwide ISO 13485 certificates in 2020, demomnstrating the growth and importance of UKAS accredited certification in recent times.

Different Ways to Learn

NQA offer e-Learning, virtual, public and in-house training options to suit all learning styles and needs. You’ll learn about how to introduce and implement an ISO 13485 Medical Devices Management System and then follow on with how to conduct internal audits to help you identify and reduce risks.

Although much of our training is currently being held virtually, we are in the process of re-introducing some options for face-to-face public courses for those that like to interact in person with others. Keep an eye out for those coming soon.

ISO 13485 Medical Devices Quality Management Virtual Training

We are continuing to run all our courses virtually so that you can attend from the comfort of your own home or office, anywhere in the country.

The training sessions are designed to give you the knowledge you need to advance and grow and are delivered by industry experts. You’ll have the chance to interact fully with both the host and other delegates over Zoom for a rounded and immersive experience, just like you would in a classroom.

ISO 13485 Medical Devices Quality Management In-House Training

If you have a slightly larger group we can offer training at your premises, which may prove more cost effective for you. This means that we can also ensure the training is tailor-made to your needs and requirements.

Benefits of In-House training:

• Cost effective and efficient – team learning reduces cost-per-head and increases return on investment from your training budget.

• Total flexibility – we deliver in-house training where and when you want in the format you need; from briefing sessions and workshops to examined courses to meet your specific objectives.

• Relevant and practical – our tutors are management systems practitioners with extensive experience of implementation, auditing and continual improvement. They’ll ensure that concepts and techniques are clearly understood and adopted.

• Team building – training in teams achieves common learning objectives, improves collaboration and increases the adoption of new techniques in practice.

• Personalised services – we take the time to fully understand your training needs and match our expert tutors to fit your organisation.

Request an In-House training quote here

Consultancy Services

After sitting on your ISO 13485 course, if you find that you might like further help with achieving certification or maintaining your management system then talk to us about our Associate Partner programme (APP). We can give you access to our fantastic database of knowledgeable consultants.

Find a Consultant here

Further Guidance and Handy Resources

• For more information on the ISO 13485:2016 Standard why not take a look at our FAQ section.

• For more information on the courses we offer, call 0800 052 2424 (option 3) and speak to a member of our team or email us at training@nqa.com.

• To learn more about certification, please sign up to our free webinars.

• Are you wondering which type of NQA training course is most suitable for you? Our Journey Guide will point you in the right direction.