Meet Our Team- Elisabeth Sadka
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
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.
We are thrilled to announce our participation in the MDI EXPO 2025, on February 18th.
Planning an FDA submission can be performed most effectively when you know which information the FDA expects from you as the legal manufacturer.
MedTech Ecosystem in Ireland and meeting our new friends & colleagues at the Global Access at the Galmont Hotel
HaMaDa Strategy for Compliance Remediation Projects
We are excited to visit the Medical Technology Ireland for the first time. As part of our continuous effort to approach the EU Medical device
Diagnostic & therapeutics, MD, SIMD, SAMD, IVD (in vitro diagnostic devices), companion diagnostic, combination devices, complex active systems, clean, sterile, biocompatible, single-use, reusable devices, home use equipment, OR equipment, Pharmaceuticals, Biologics, Genetics.
Cardiovascular, Endocrinology & Metabolism (Diabetes, Osteoporosis), Urology, Infectious diseases, Ophthalmology, Gynecology, Musculoskeletal, Neurology, Neurosurgery, Dentistry, Plastic Surgeries, Esthetics, Pain, Pediatrics, Neonatology, Oncology, Orthopedics, Respiratory, Esthetics.
