New Courses to Reach New Heights in 2025

I want to take the opportunity with my first blog of the new year to talk about new courses Comply Guru have launched for 2025. These new courses offer a more flexible way to upskill and gain ‘industry-leading’ credentials in the complex, ever-changing world of standards & regulations within MedTech and the Life Sciences.

Our growing portfolio now includes 23 courses for Quality and Regulatory Affairs (QA/RA) Professionals in the Medical Device Industry across eLearning, Blended Learning & Live Learning Formats, with more in the pipeline.

What really separates Comply Guru from other providers?

Simply put, our market-leading position for innovation within the training space.

Comply Guru have successfully launched ‘first of a kind’ courses where never before was such comprehensive training available on standards and medical device regulations via eLearning, and never before was it possible to be trained as an Internal Auditor or Lead Auditor with 50% less classroom time, which was achieved using our industry-leading Blended Learning Methodology.

We achieved this by working closely with leading professional bodies including CQI and IRCA as well as Exemplar Global to ensure the training was globally recognized.

Our training is now trusted by Competent Authorities, several notified bodies in Europe, as well as many of the most well known Medical Device Manufacturers in the world.

What new training courses are available in 2025?

During 2024, we were experiencing a growing demand for more specialized training on important topics including ISO 14971, CAPA and the European Medical Device Regulation (EU MDR 2017/745).

For 2025, we are now able to offer four new training courses to help customers achieve new heights in the year ahead:

Advanced Risk Practitioner via Blended Learning (18hrs)

This course builds on our existing ISO 14971 Requirements eLearning (12hrs) to add an additional 1-day live workshop, led by an experienced Practitioner, where Learners will focus on the best practice skills to equip them to readily apply the knowledge and tools successfully within their organization.

During the 1-day live workshop, upon successful completion of the eLearning modules, Learners will collaborate and work with more case studies and scenarios to help deepen their understanding of the requirements, and application of the tools and techniques in a real life context.

To learn more about this new Advanced Risk course, you can view the details here.

CAPA Practitioner via Blended Learning (16hrs)

CAPA is always one of the most raised findings by the FDA year after year. It is an area that is so frequently found as a weakness in many organizations. Comply Guru offer a 2-day instructor-led, practical training on CAPA.

From March, this course will be available as a hybrid of eLearning (7hrs) plus 1-day live workshop. It covers CAPA requirements, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.

Learners will first master the underlying theory of CAPA via eLearning, before attending focused workshops with an experienced Practitioner, to enhance their knowledge by working through practical case studies and scenarios of every stage during the CAPA process, to ensure that they can successfully apply what they have learned back in their organization.

To learn more about this new CAPA Practitioner course, you can view the details here.

Post Market Surveillance (PMS) under the EU MDR via Live Learning (16hrs)

This is a critical area under the EU MDR and something we see as of huge interest to Medical Device manufacturers.

This interactive course is designed to equip quality and regulatory professionals, medical device manufacturers, and post-market teams with the knowledge and tools to meet these rigorous requirements. From understanding the legal framework to developing a compliant PMS Plan, this course covers every essential aspect of PMS under EU MDR.

To learn more about this new Post Market Surveillance under the EU MDR course, you can view the details here.

Clinical Evaluation Reporting under the EU MDR via Live Learning (7hrs)

Similar to PMS, this is another area that is frequently coming up as an area that QA/RA Professionals need more guidance and training on. This course will offer a deeper dive into the requirements under the EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4.

Through interactive modules and case studies, Learners will be guided on how to navigate clinical data collection, evaluation planning, CER preparation, and Post-Market Clinical Follow-Up (PMCF).

To learn more about this new Clinical Evaluation Reporting under the EU MDR course, you can view the details here.

More Medical Device Training Courses Coming Later in 2025

Comply Guru are not stopping there!

More courses are coming later in 2025 so stay tuned via our website or LinkedIn page to stay abreast of the latest news, insights and updates regarding all things Comply Guru and MedTech.