Celegence, a provider of regulatory affairs services and solutions for the life sciences industry, has added new features to CAPTIS to help produce compliant Post Market Surveillance (PMS) documentation more efficiently.
To comply with the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) device and diagnostic manufacturers are required to produce and maintain various documentation such as Clinical Evaluation Reports (CER) and Post Market Safety Reports. Writing these reports is a complex process and CAPTIS, a cloud solution, now features a report writing module designed to help medical writers manage systematic literature reviews more efficiently, streamline document lifecycle management, and facilitate the first-time acceptance of regulatory documentation by Notified Bodies.
Medical writing teams must write and maintain a significant amount of documentation for a single device. CAPTIS automates this process, saving many hours of manual effort as well as significantly reducing the propensity for human error. By integrating seamlessly with databases such as PubMed and Google Scholar, it streamlines the screening and assessment of literature. A master data “dictionary” allows relevant information to be used consistently across various reports for the same device or device family.
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 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 recognised 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 recognise 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.”