HaMaDa is a consulting firm with over 15 years of Regulatory, Compliance and Clinical Affairs expertise in the Medical Device, SiMD, SAMD, AI, ML and Digital Health Markets. Our seasoned consultants have been supporting leading companies in various expertise domains.

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Establishment and implementation of Quality Systems to comply with ISO 13485, MDR, IVDR, MDSAP & FDA-QSR; Establishing eQMS; Execution of quality audits and mock FDA audits; Vast experience with FDA compliance requirements and implementation; QA Engineering tasks, V&V support; Remediation projects.

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Development of regulatory strategies; Guidance in the implementation of regulatory requirements through the Design and Market Phases; Regulatory Submissions (FDA, CE, Global Regulations); Support ongoing regulatory tasks such as risk management, complaint management, CAPA & ECO processes; SW QA; Cybersecurity; Information Privacy, registration & listing and more

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MEDICAL WRITING

Regulatory, Medical and Scientific Writing for the Medical Device and IVD industry including CEP & CER, PEP & PER, PMS, PSUR, PMCF, SSCP and preparation of scientific publications.

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CRO - CLINICAL STUDIES

Full CRO services: Submission Packages to IRB; Clinical Investigation Plans (SIP, Study Protocol); Investigators Brochure (IB); Informed Consent form (IC); Case Report Form (CRF); Management & Conduct of clinical studies from submission through initiation and monitoring until study closure; Development of EDC/eCRF & eTMF solutions.

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INFORMATION SECURITY&PRIVACY

In the era of connected care, patient safety extends beyond physical devices to the data they generate and cybersecurity is now a critical regulatory requirement. We guide medical device and digital health companies through the complex landscape of global cybersecurity and privacy regulations, ensuring your technology remains compliant, secure, and trusted.

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At HaMaDa, we are the trusted leaders in the field of medical device consulting. With a dedicated team of experts and a global perspective, we provide crucial services to bring your medical innovations to life.

EXPERTISE

STRATEGY

DESIGN PHASE

Device Requirements
RMF (Risk Management)
Usability
Product Validation
DHF
VMP, V&V
SDLC
Cyber Security
Information Privacy

MANUFACTURING

Transfer To Production
CAPA
ECO
DMR, DHR
IQ, OQ, PQ
Agreements
Subcontractors
Turn Key

QUALITY SYSTEM

CRO

Submission File
Clinical Trial Conduct
Clinical Trial Management (CIP, ICF, IB; eTMF, SOPs, CSRs)
Clinical Writing (synopsis, protocol, articles)
Monitoring
Site Inspection
Study Management
EDC / eCRF

REGULATORY SUBMISSIONS

AUDITS

SALES PHASE

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