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For medical device developers, connecting user needs with clinical evidence requirements isn’t just a regulatory checkbox—it’s a strategic advantage. When user needs are clearly defined

HaMaDa has extensive experience in the ophthalmic devices sector, providing regulatory, quality assurance, and clinical services to a variety of innovative technologies. This includes contributing

Performance Evaluation is a dynamic, lifecycle process critical for Medical Device Software (MDSW) under IVDR

🔄 For those of you who follow us and may have missed our webinar on: Winning the MDR Challenge Focus on Critical CER Aspects ,You

Daniele Perl-Treves, PhD (Weizmann Institute of Science), brings over 20 years of expertise in the medical device industry, ensuring the successful preparation of regulatory and

Implementing a Quality Management System (QMS) under ISO 13485 for SaMD? It’s a whole different ballgame than dealing with hardware products! 🎮 But fear not—our

In the highly regulated medical device industry, internal audits are not just required; they are essential! Conducting regular internal audits is a proactive step toward

Elevate Your Orthopedic and Robotic Surgery Innovations with HaMaDa Consulting!

At HaMaDa Consulting, we specialize in establishing robust and lean Quality Management Systems (QMS) for medical device companies 🏥.

With over 25 years in the medical device industry, Elisabeth Sadka, M.Sc., MBA, leads HaMaDa Consulting’s Regulatory Affairs (RA), Quality Assurance (QA), and Clinical Writing

In Vitro Diagnostic Regulation (IVDR): What You Need to Know – Part 2

In Vitro Diagnostic Regulation (IVDR): What You Need to Know – Part 1

This new regulatory framework represents a significant shift in how LDTs are overseen in the United States, aiming to ensure the safety and effectiveness of

💡 Hamada consultants can provide you with the adequate support to navigate this UDI implementation.

The Engineering Change Order (ECO) process is the cornerstone of this management, requiring significant effort and cross-departmental collaboration. It aligns with the principles outlined in

In 2008, Sarit Gal-Rom founded HaMaDa Consulting as a boutique firm specializing in Regulatory Consulting. What began as a solo endeavor has grown into a

In the cutthroat world of medical device regulation, relying solely on FMEA is like playing roulette with your company’s future.

The Clinical Evaluation Report (CER) is a cornerstone of CE registration under the Medical Device Regulation (MDR), providing a detailed assessment of a medical device’s

Unlock the Power of Early Clinical & Regulatory Planning in Medical Device Development

HaMaDa CRO supercharges your medical device journey from concept to market approval!

HaMaDa Consulting offers the expertise you need to navigate these complexities and accelerate your path to market.

Planning an FDA submission can be performed most effectively when you know which information the FDA expects from you as the legal manufacturer.

HaMaDa Strategy for Compliance Remediation Projects