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OUR SERVICES
Unlock Your Business with Consulting Services
Our company offers a personalized and unique service tailored to each client, whether they are small startups or leading giants
510k
We provide 510k Medical Device (MD) consulting services to medical device companies in Israel. Our services are available for specific projects or individual
CE marking
We are ready to fully support your CE Marking transition from the Medical Devices Directive (MDD) to the Medical Devices Regulation (MDR)
ISO 13485 and ISO 9001
Quality Management System (QMS) Compliance We make sure a QMS that your Company meets the QMS specifications and requirements through
Auditing
Audits are executed to determine regulatory compliance and improve effectivity of your processes and those of your critical subcontractors and suppliers
Sterilization Validation / Microbiology
Sterilization validation and microbiological control are crucial for ensuring medical device safety and preventing infections
Microbiology Process Evaluation
Environmental control is crucial for GMP, with ongoing monitoring essential for effective microbiological control
