OVERVIEW
A fast-growing medical device manufacturer specializing in devices for the clinical challenges of upper extremity surgery
Skeletal Dynamics, headquartered in Miami, FL, are a fast-growing medical device manufacturer specializing in devices for the clinical challenges of upper extremity surgery.
Each year, Skeletal Dynamics needs training for new & existing team members on understanding the requirements ISO 13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) as well as training for ISO 13485 Lead Auditors who will perform internal and supplier audits.
Before working with Comply Guru, team members were registered for ‘online training’ that was being offered by other leading U.S providers, but found that it was not effective or good ROI. As a result, Skeletal Dynamics would only consider sending staff to in-person training. This was often expensive, included additional fees and travel expenses, and was seen as a barrier to getting the team fully trained within budget.
Since 2021, Comply Guru has been annually selected as a preferred training provider in the U.S where online learning replaced in-person learning for training QA/RA team members for:
eLearning for Knowledge
eLearning is the most flexible way to learn Anywhere, Anytime. Learners are empowered with 24/7 access to the ‘best in class training’ they need when they need it. Comply Guru’s eLearning courses are designed by experienced subject matter experts & instructional designers, benchmarked against international specifications and are independently assessed by globally recognized professional bodies such as CQI & IRCA.
Blended Learning for Skills
Blended Learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending virtual instructor-led classes that develop practical, real-world skills that can be instantly applied back in the workplace. This combines the best of two online formats to ensure not only maximum flexibility while completing the training, but also maximum learning effectiveness.
When asked “why he chose Comply Guru”, Mario Arbesu, VP of Quality Assurance & Regulatory Affairs, said:
“Over the years, I have used many well-known U.S training providers, but I found Comply Guru had truly mastered ‘online’ training which has saved Skeletal Dynamics over 50% in training fees, associated expenses as well as 100% of the time lost spent travelling to training with other providers.”
Comply Guru has annually trained members of Skeletal Dynamic’s QA/RA team through online learning including both eLearning & Blended Learning. The following benefits have been achieved:
“I would highly recommend Comply Guru! The quality of their training courses is second to none and their customer service is excellent!”