HaMaDa
H.M.Da Consulting & Development Ltd. is a consulting firm with over 15 years of expertise in Regulatory, Compliance, and Clinical Affairs in the Medical Device, SiMD, SAMD, AI, ML, and Digital Health sectors. They support leading companies in various domains, providing crucial services to bring medical innovations to life. Their mission is to guide companies through complex regulatory landscapes, ensuring successful product launches and market sustainability.
Industries
Nr. of Employees
small (1-50)
Services
Regulatory strategy development, preparation and submission of dossiers for global markets, and ongoing regulatory support for product registration and compliance.
QMS gap analysis, implementation, training, internal audits, eQMS deployment and preparation for ISO 13485, MDSAP and FDA QSR compliance.
Full clinical services including protocol and submission preparation, IRB/ethics submissions, site monitoring, clinical data management and eClinical system support through study closeout.
Preparation of regulatory and scientific documentation including clinical evaluation reports, performance evaluation reports, PMS documentation and clinical study reports.
Execution of internal and external audits, mock inspections and remediation planning to address nonconformities and implement CAPA activities.
Regulatory strategy development, preparation and submission of dossiers for global markets, and ongoing regulatory support for product registration and compliance.
QMS gap analysis, implementation, training, internal audits, eQMS deployment and preparation for ISO 13485, MDSAP and FDA QSR compliance.
Full clinical services including protocol and submission preparation, IRB/ethics submissions, site monitoring, clinical data management and eClinical system support through study closeout.
Preparation of regulatory and scientific documentation including clinical evaluation reports, performance evaluation reports, PMS documentation and clinical study reports.
Execution of internal and external audits, mock inspections and remediation planning to address nonconformities and implement CAPA activities.
Expertise Areas
- Regulatory affairs for medical devices and in vitro diagnostics
- Quality management systems and audit readiness (ISO 13485, FDA QSR, MDSAP)
- Clinical trial design and management (ICH-GCP, ISO 14155)
- Medical and regulatory writing for conformity and post-market documentation
Key Technologies
- Software as a Medical Device (SaMD)
- Artificial intelligence / machine learning
- Electronic data capture (EDC/eCRF)
- Electronic trial master file (eTMF)
News & Updates
HaMaDa is participating in RAPS Euro Convergence 2025, on May 13-16.
HaMaDa will participate in MDI EXPO 2025, on February 18.
Meeting at the MedTech Ecosystem in Ireland at the Galmont Hotel.
Celebrating 7 Years of Growth and Impact – Shai Ben-Efraim at HaMaDa Consulting.
HaMada leverages a team of seasoned medical writers with diverse clinical and scientific expertise.
Supporting Israel’s thriving medical device and digital health industry for over 17 years.
HaMaDa is participating in RAPS Euro Convergence 2025, on May 13-16.
HaMaDa will participate in MDI EXPO 2025, on February 18.
Meeting at the MedTech Ecosystem in Ireland at the Galmont Hotel.
Celebrating 7 Years of Growth and Impact – Shai Ben-Efraim at HaMaDa Consulting.
HaMada leverages a team of seasoned medical writers with diverse clinical and scientific expertise.
Supporting Israel’s thriving medical device and digital health industry for over 17 years.