CAPTIS Deep Dive – MDR & IVDR Compliance Technology

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.

Systematic Literature Reviews (SLRs) are a vital component of CERs and PERs, and CAPTIS offers medical writing teams a solution to improve their collaborative efforts needed for compliance. A sleek interface and time-saving workflows with database integrations are not the only objectives of the platform: we also prioritized improved compliance and reproducibility of data. Review processes are also critical in ensuring accuracy, and in CAPTIS, you can directly tag your team members and highlight relevant portions for others to review. This can all be done while the entire team is online, working on the document at the same time.

See snapshot #1 for a look at how the tagging feature works within the platform.

This snapshot gives you a glimpse into CAPTIS’ project overview interface. Meeting tight deadlines can be difficult, but your team will ensure milestones are met with CAPTIS.

For a comprehensive demo on how CAPTIS improves search string organization and overall research practices, we encourage you to reach out today.

This 2nd snapshot gives you a glimpse into CAPTIS’ project overview interface. Meeting tight deadlines can be difficult, but your team will ensure milestones are met with CAPTIS.

While CAPTIS is an exceptional technology on its own, Celegence is able to supplement the technology solution with our expansive team of subject matter experts. Our client base is of all sizes, thus, our offerings reflect varying needs and gaps. Smaller teams facing aggressive deadlines with multiple CERs a year may need access to the CAPTIS platform to streamline work for internal teams, while also tapping into consulting support from Celegence regulatory experts and medical writing teams. The platform allows for seamless collaboration between our internal team and a clients’.

While a larger medical writing team may not need the extra hands to actually write the documentation, it would still be critical that their internal teams are able to maximize efficiency, stay organized, on track, and have widespread alignment. As described, project managers will always have access to up-to-the-second status updates and oversight with CAPTIS.

To learn more and view a comprehensive demo of CAPTIS, reach out to info@celegence.com today or contact us online to connect with a Celegence representative.