The recent U.S. FDA draft guidance for AI-enabled #Medicaldevices provides recommendations for marketing submissions and lifecycle management to support their safety and effectiveness evaluation. #artificial_intelligence #Compliance fda.gov/regulatory-inf…

#Reading #SPOTLIGHT Exclusive copy of our first regulatory white paper: heyzine.com/flip-book/c189… Simplify your journey to market with insights from this white paper on Medical Device Classification in the US! Chetna Dharmavat Dabi

The recent ICH guideline promotes a risk-based and proportionate approach to clinical trials, prioritizing participant safety, data reliability, and ethical compliance. Read the full guideline here: database.ich.org/sites/default/… #clinicaltrial #updates #Drugs

📃 Whether you're a small #startup or an established player, investing in a robust QMS isn't just smart—it's essential for ensuring product #quality, effectiveness and compliance. VentureCenter ISO Premnath V Chetna Dharmavat Dabi #standard #safety #ISO13485

The TGA Australia announces preview of new Procedure for Product #Recalls, #Alerts, and #Corrections (PRAC) which will be effective from March 2025. Read more: tga.gov.au/news/news/reca… VentureCenter Premnath V Chetna Dharmavat Dabi

#LatestNews the IMDRF AI/ML Working Group released final guidance on 'Good machine learning practice (GMLP) for medical device development: Guiding principles', outlining 10 principles to ensure safe and effective AI/ML device development. Read More: imdrf.org/documents/good…

#UPDATE The IMDRF #SaMD WG has released a final doc that aims to help identify and assess software-specific risks, including cybersecurity and information-based hazards. #cybersecurity2025 #RiskManagement #artificial_intelligence Read more: imdrf.org/documents/char…

VACCINES: CDSCO_INDIA_INFO has granted approval to #BioVet's vaccine #BIOLUMPIVAXIN for Lumpy Skin Disease in dairy cattle. It is the world’s first-ever DIVA marker vaccine. Read: biovoicenews.com/cdsco-grants-a… via #BiovoiceNews Bharat Biotech #animalhealth #animalvaccines

The CDSCO_INDIA_INFO launches registration of Clinical Research Organisation (CRO) applications (Form CT07B) through its SUGAM portal. For detailed application process: cdsco.gov.in/opencms/opencm… #SUGAMportal #ClinicalResearch #ClinicalTrials Chetna Dharmavat Dabi

Huge learning opportunity for #techtransfer professionals in India! Join a 5-day online #webinar on Essentials of Technology Transfer with renowned global and national experts. 📅 21–25 April 2025 | Online via Zoom 📌 Register now: docs.google.com/forms/d/e/1FAI… UNIDO CSIR-National Chemical Laboratory

📷 Exciting news for tech transfer professionals in India! We’ve launched Tech Transfer Online – a dedicated platform to build community, share knowledge & grow capacity in tech transfer : techtransfer.online (1/3)

Built by VentureCenter under the FLCTD-Facility for LowCarbon Technology Deployment project of UNIDO-Bureau of Energy Efficiency (ऊर्जा दक्षता ब्यूरो)-@GEF, this platform offers: -- Join community & discussion forums -- Events & expert-led training -- Learning resources (coming soon!) techtransfer.online/join-community/ (2/3)

Check out CDSCO_INDIA_INFO's latest draft on the revision of risk-based classification lists of #MedicalDevices in below categories: Cardiovascular devices (Total : 351) Neurological devices (Total : 202) Read more: cdsco.gov.in/opencms/opencm… Chetna Dharmavat Dabi

#PublicNotice Provision for system auto-generated Neutral Code by the #manufacturer for the export purpose under #Medicaldevices Rules, 2017-reg. Read More: cdsco.gov.in/opencms/opencm…

#LatestUpdates ISO 11137-1:2025 (Sterilization of health care products — Radiation) update that includes a clearer structure, increased radioactivity limits, enhanced process controls, and streamlined dose verification. Know more: iso.org/standard/81721…

Our #LATEST whitepaper on the step-by-step US medical device classification guide is now featured in BioSpectrum Magazine’s May 2025 edition! #FDAApproval Full Download :venturecenter.co.in/whitepapers/1/… Biospectrum Article :biospectrumindia.com/views/17/26047… Chetna Dharmavat Dabi