Comply Guru Gains RAPS Approved Provider Status

Comply Guru are delighted to announce that we are now an Approved Training Provider (No. 1007) with the Regulatory Affairs Professionals Society (RAPS) adding further global recognition for our training within MedTech for Quality and Regulatory Affairs Professionals.

As Eoin Philip Kelly, Founder and CEO, explains “This is a landmark achievement. In 2019, fueled by a passion for Innovation Comply Guru started a journey into MedTech to offer courses that were more accessible & flexible than what was available, but still globally recognized with CQI & IRCA and Exemplar Global. This new tier of accreditation with RAPS offers to bring more global recognition for training across a broader scope of topics for a fast-paced, ever-changing Industry – and we are very excited to be one of the early entrants within the space.”

About RAPS

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health.

From membership, global events, personnel certification to education – RAPS is enhancing its offerings within the training space and this pivot to recognize training providers who meet their criteria, is an exciting new chapter that Comply Guru is proud to be a part of.

RAPS Recognized Courses

As of 27th February 2025, RAPS Credits are now available for the following six (6) online courses with Comply Guru:

FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors (12 credits)

This 16hr eLearning course is for Practitioners and Auditors who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (Revised Part 820).

MDSAP Requirements for Practitioners and Auditors (12 credits)

This 12hr eLearning course is for Practitioners and Auditors that provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

EU IVDR 2017/746 Requirements for Practitioners (12 credits)

This 24hr eLearning course takes you through the new European In Vitro Diagnostic Regulation (2017/746), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.

EU MDR 2017/745 Requirements for Practitioners (12 credits)

This was the first internationally accredited training course in the world on the EU MDR (with CQI & IRCA). A 24hr eLearning course that takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. This course has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.

ISO 14971 Requirements for Practitioners and Auditors (10 credits)

This was the first internationally accredited training course in the world on Medical Device Risk Management based on ISO 14971:2019. A 10hr eLearning course for Practitioners and Auditors that provides a comprehensive overview of the international standard for risk management for medical devices.

Person Responsible for Regulatory Compliance (PRRC) (5 Credits)

This 6hr eLearning course provides clarity on the role and responsibilities of the Person Responsible for Regulatory Compliance (PRRC) introduced under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and provide details on the qualifications and liabilities that exist for PRRCs.

Comply Guru will be adding more courses soon so stay tuned for more updates! If you have any questions about any of our courses or need some tailored training, our team are standing by, get in touch today!