Celegence provides report writing performance to EU MDR and IVDR compliance expertise, CAPTIS™, to assist streamline medical writing and doc upkeep
CHICAGO, July 6, 2022 /PRNewswire/ — Celegence, a world supplier of regulatory affairs companies and options for the life sciences trade, has right this moment introduced the addition of recent options to CAPTIS™ to assist the gadget and diagnostic trade produce compliant Put up Market Surveillance (PMS) documentation extra effectively.
To adjust to the EU Medical System Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) gadget and diagnostic producers are required to supply and keep varied documentation equivalent to Medical Analysis Experiences (CER) and Put up Market Security Experiences. Writing these stories is a posh and laborious course of and CAPTIS™, a safe, user-friendly cloud resolution, now encompasses a report writing module designed to assist medical writers handle systematic literature evaluations extra effectively, streamline doc lifecycle administration, and facilitate the first-time acceptance of regulatory documentation by Notified Our bodies.
Medical writing groups should write and keep a big quantity of documentation for a single gadget. CAPTIS™ automates this course of, saving many hours of guide effort in addition to considerably lowering the propensity for human error. By integrating seamlessly with databases equivalent to PubMed and Google Scholar, it streamlines the screening and evaluation of literature. A grasp knowledge “dictionary” additionally saves time by permitting related data for use persistently throughout varied stories for a similar gadget or gadget household.
Celegence began constructing CAPTIS™ in 2019 because it foresaw the compliance challenges dealing with medical gadget producers would face, for the reason that firm additionally gives consultancy and regulatory companies to the units and diagnostics trade. Producers can use this web-based resolution by means of their very own medical writing group or in collaboration with Celegence’s medical writers as an extension of their group.
Punya Abbhi, COO at Celegence stated: “As service suppliers to the trade, we recognize the operational calls for of getting ready complicated, compliant medical gadget stories as we face them as nicely. Now we have invested within the analysis and growth of CAPTIS ™ resolution to particularly tackle the challenges confronted by gadget producers.
“Our aim with CAPTIS™ is to enhance outcomes for the life sciences trade. We acknowledged the necessity to drive course of efficiencies within the growth of those stories and finally assist medical gadget and diagnostic producers obtain and keep MDR & IVDR compliance.
“Along with bringing efficiencies to medical writing and doc upkeep, CAPTIS additionally helps enhance the assessment course of for Notified Our bodies. As medical writing professionals, we work carefully with Notified Our bodies and acknowledge the pressures they face in terms of reviewing enormous volumes of data and references for every submission. Submitting these paperwork utilizing CAPTIS ensures they’re simply accessible and introduced in compliant templates which might be Notified Physique authorized.”
System and diagnostic producers are being invited by Celegence to expertise CAPTIS for themselves. To rearrange a demo please contact a Celegence consultant right this moment at [email protected].
About Celegence
Celegence helps life sciences corporations navigate complicated world regulatory necessities by offering consulting companies and options devoted to regulatory affairs. Celegence helps life sciences prospects within the areas of EU MDR compliance, IVDR compliance, regulatory intelligence, RIMS knowledge administration, publishing, regulatory labeling together with UDI consulting, medical writing and compliance with new rules for various product portfolios. Celegence’s depth of expertise and in depth supply functionality permits regulatory affairs and high quality groups to function extra effectively, scale back value, and enhance compliance. For extra data, go to www.celegence.com or observe Celegence on LinkedIn.
For additional data please contact:
Rachel Hollos
Advertising and marketing director at Celegence
[email protected]
Press contact:
Fiona Whyatt
Senior PR supervisor at ramarketing
[email protected]
SOURCE Celegence
