While our CAPTIS EU MDR & IVDR Technology was only recently introduced to the industry, the Celegence medical writing team has been using the tool since 2020. When developing this technology, it was evident there were glaring gaps in the functionality of other literature review and regulatory documentation softwares available at the time. Our medical writing team faced operational difficulties with version control, oversight, and overall collaboration, especially with larger volumes of work. Additionally, it was evident that seamless database integrations were a critical requirement to streamline the systematic literature review process. Commonly used databases like PubMed and Google Scholar, as well as Adverse Event Databases such as US FDA MAUDE, became a major focus in the development of the technology.
Medical device manufacturers and consultants have long had their processes outlined for previously compliant documentation. While acceptable at the time, these out-dated methodologies are far from ideal now that both the MDR and IVDR require far more effort and data analysis. For years, device technology was evolving, but the documentation and compliance processes remained the same. It was clear to us there was going to be an inherently large learning curve for the MDR and IVDR. We recognized that system onboarding and training was going to be a crucial component of ensuring a smooth transition to the CAPTIS technology. Since the Celegence team was the first to use the platform, we are able to offer training that is reflective of the practical needs of the end user.
Industry wide, there are consistent obstacles with producing compliant CERs and PERs in an efficient manner. With the overall expansion of requirements for EU market access, documentation now takes far longer, and requires more medical writers and experts to work on the same material (articles, source documents, adverse event data, etc.) simultaneously. Literature searches were especially difficult with previous research practices, with consistent citations becoming especially inefficient and time-consuming.