CyMedica orthopedics, a Medical Device company, that already had a CE mark on their products, needed to change their quality management system to meet the new European regulation.
Our company, Delta Consulting Alliance was brought in to perform a gap analysis and to make sure that CyMedica Orthopedics was compliant and could continue their business seamlessly before the May 26th, 2021 deadline.
Through the gap analysis, we were able to identify key items to address in order to meet the requirements in a timely manner.
As Jackie says in this short video, most of this project was assigned to her and she’s only one person with other projects to complete.
Being a small company, CyMedica Orthopedics didn’t have a large team to make sure these requirements were handled properly and didn’t cause any business flow disruptions and fall out of regulations.
Delta was able to help get CyMedica Orthopedics compliant with EUMDR standards and when audited by BSI, zero observations were found — which is not typical for this industry.
We are incredibly happy that we were able to contribute to CyMedica Orthopedics success during this regulator transition.