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 providers and options for the life sciences business, has right now introduced the addition of latest options to CAPTIS™ to assist the gadget and diagnostic business produce compliant Publish 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 provide and keep varied documentation similar to Medical Analysis Experiences (CER) and Publish Market Security Experiences. Writing these experiences is a posh and laborious course of and CAPTIS™, a safe, user-friendly cloud answer, now incorporates a report writing module designed to assist medical writers handle systematic literature critiques 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 major quantity of documentation for a single gadget. CAPTIS™ automates this course of, saving many hours of guide effort in addition to considerably decreasing the propensity for human error. By integrating seamlessly with databases similar to PubMed and Google Scholar, it streamlines the screening and evaluation of literature. A grasp knowledge “dictionary” additionally saves time by permitting related info for use persistently throughout varied experiences for a similar gadget or gadget household.
Celegence began constructing CAPTIS™ in 2019 because it foresaw the compliance challenges going through medical gadget producers would face, because the firm additionally offers consultancy and regulatory providers to the units and diagnostics business. Producers can use this web-based answer via their very own medical writing staff or in collaboration with Celegence’s medical writers as an extension of their staff.
Punya Abbhi, COO at Celegence stated: “As service suppliers to the business, we respect the operational calls for of getting ready complicated, compliant medical gadget experiences as we face them as effectively. We now have invested within the analysis and improvement of CAPTIS ™ answer to particularly handle the challenges confronted by gadget producers.
“Our objective with CAPTIS™ is to enhance outcomes for the life sciences business. We acknowledged the necessity to drive course of efficiencies within the improvement of those experiences and in the end 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 the case of reviewing large volumes of data and references for every submission. Submitting these paperwork utilizing CAPTIS ensures they’re simply accessible and offered 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 now at [email protected].
Celegence helps life sciences firms navigate complicated world regulatory necessities by offering consulting providers and options devoted to regulatory affairs. Celegence helps life sciences clients 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 laws 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 info, go to www.celegence.com or comply with Celegence on LinkedIn.
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