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Home
About Us
Our Team
Our Clients
Services
Regulatory Consulting
EU MDR & IVDR Consulting
EU MDR Clinical Evaluation
PRRC
ISO 13485 & QMSR
Writing SOPs
Quality Agreements
Economic Operators
Trainings & Education
FDA Submissions
Risk Management
Medical Device Cybersecurity
Market access
Preclinical CRO support
Clinical CRO support
Israel Medical Device Registration
Biostatistical Consulting
Protection of Technology
Israel Devices Registration
EU-MDR
EU MDR CE Certification
Gap Analysis MDD-MDR transition
EU MDR Clinical Evaluation
Literature Review
PMS & Vigilance
PMCF
Risk Management
Biological & Chemical Evaluation
Importers Obligations
Distributer obligations
Supply chain identification
EU declaration of conformity
Virtual manufacturing
EU MDR Quality Procedures
Audits
Trainings
Products
Medical Devices
AI, Software & Digital Health
Combination products
Israel Cosmetics Registration
PPE
Veterinary Products
Homeopathic Products
Borderline products
Cosmetics Registration
Marketing Notification
Product Development
EU Auth. Representative
UK Responsible Person
GDPR – Data Protection
Blog
Contact
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Our Team
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Our Team
Daniel Albahari M.Sc., RAC
Founder & Managing Director
Yu Zhao, MBA
Head of FDA & Digital Health Department
Mark Kwiecinski, M.Sc.
Head of Health Canada & Cannabis Department
Jelena Markovic Popović LL.B
Head of Legal & Information Department
Igor Lazarević, M.Sc.
Head of Business Development
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