Celegence started building CAPTIS™ in 2019 as it foresaw the compliance challenges medical device manufacturers would face, since the company also provides consultancy and regulatory services to the devices and diagnostics industry. Manufacturers can use this web-based solution through their own medical writing team or in collaboration with Celegence’s medical writers as an extension of their team.
Punya Abbhi, COO at Celegence said: “As service providers to the industry, we appreciate the operational demands of preparing complex, compliant medical device reports as we face them as well. We have invested in the research and development of the CAPTIS™ solution to specifically address the challenges faced by device manufacturers.”
“Our goal with CAPTIS™ is to improve outcomes for the life sciences industry. We recognized the need to drive process efficiencies in the development of these reports and ultimately help medical device and diagnostic manufacturers achieve and maintain MDR & IVDR compliance.
“In addition to bringing efficiencies to medical writing and document maintenance, CAPTIS™ also helps improve the review process for Notified Bodies. As medical writing professionals, we work closely with Notified Bodies and recognize the pressures they face when it comes to reviewing huge volumes of information and references for each submission. Submitting these documents using CAPTIS™ ensures they are easily accessible and presented in compliant templates that are Notified Body approved.”