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EU Pilot Coordinated Assessment updates

EU Launches Pilot Coordinated Assessment Program for CI/PS: What Medical Device Sponsors Need to Know
Modeling degradation kinetics of biomedical polymers used in implantable medical devices through hydrolysis, oxidation, and Arrhenius-based modeling

Modeling Degradation Kinetics of Biomedical Polymers Used in Implantable Devices
FDA updates Pre-RFD guidance with new recommendations for medical device, drug, and biologic classification.

FDA Issues Revised Pre-RFD Guidance: What Industry Needs to Know
FDA Draft Guidance on QMSR for Premarket Submissions

FDA Issues Draft Guidance on QMSR Information for Premarket Submissions
Notified Bodies Warn Shortage Could Hinder AI Regulation

Notified Bodies Warn Shortage Could Hinder AI Regulation
MHRA CEO Highlights Risk-Proportionate Regulation for AI & Medical Devices

MHRA Plans Risk-Proportionate AI and Medical Device Oversight
MedTech industry experts discussing proposed reforms to MDR and IVDR regulations.

MedTech Industry Urges Comprehensive Reforms to MDR and IVDR
Illustration showing AI technology and FDA evaluation concept for medical devices

FDA Seeks Feedback on Real-World Performance of AI Medical Devices
FDA’s ASCA program helps medical device makers streamline compliance and submissions.

FDA’s ASCA Program: Transforming Medical Device Compliance
AI and regulatory trends shaping the future of inflammation imaging in healthcare

Future of Inflammation Imaging: Regulatory Trends, increasing role of AI and Industry Insights
MedTech downsizing guidance ensuring compliance with Elexes

Navigating Downsizing in the Medical Device Industry: Ensuring Compliance and Operational Continuity with Elexes
FAQs on EU Medical Device Regulation

FAQs – EU Medical Device Regulation (EU MDR 2017/745)
Comprehensive guide to medical device testing for safety and regulatory compliance

Medical Device Testing Requirements: A Complete Guide
When is a new 510(k) Submission Required as per the FDA

When is a new 510(k) Submission Required as per the FDA?
510(k) Submissions in 2025: Key Updates and Insights

What’s New for 510(k) Submissions in 2025? Key Updates and Insights

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