OVERVIEW
A globally recognized and leading Notified Body in the Medical Device Industry
TÜV SÜD Product Service GmbH (TÜV SÜD) is a globally recognized and leading Notified Body that facilitates access to international markets through Medical Devices & IVD market approval and certification for the MedTech industry worldwide.
Each year, TÜV SÜD must ensure their Auditors are well-equipped with the necessary knowledge and skills to conduct audits aligned with ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes). Furthermore, these Lead Auditors are required to complete CQI & IRCA Certified Training, considered the ‘gold standard’ in auditor training globally.
CQI & IRCA Certified Lead Auditor Training requires Learners to undertake a minimum of 40hrs (5-days ) of training, and successfully complete continuous assessments as well as an end of course examination to attain certification.
In 2021, Comply Guru was appointed as a preferred training provider by TÜV SÜD to deliver CQI & IRCA Certified ISO 13485 Lead Auditor Training through a blended learning approach.
Blended learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending live, instructor-led classes emphasizing practical, real-world application.
“Comply Guru’s training provided us with a solid grounding in regulatory practices, enriched with practical tips, tricks, and insights from the trainers’ own experiences, thoroughly preparing us for the demands of our daily business. The interactive format of the classroom sessions facilitated valuable exchanges between the trainers and participants, enhancing our learning experience”
Since 2021, Comply Guru has consistently delivered this training to TÜV SÜD multiple times each year. The combination of advanced technological platforms and innovative learning methodologies has yielded several significant benefits:
TÜV SÜD particularly praised Comply Guru for not only adhering to legal norms but also understanding the nuances of their business. They highlighted how Comply Guru adds a personal touch to the training, making it more relatable, engaging and effective for participants.
“Blended Learning started as an innovative approach to bring the best of two worlds together and it has now become a proven, trusted & more flexible way to get globally recognized training”