Description:Delivering industry standard, regulation compliant solutions to the medical device industry in more than 85 countries that includes GCC. All classes of medical devices, combination products, radiation emitting devices and IVDs
More than fifteen years experience in: New product design, high volume production planning, quality management systems, risk management, software, systems and process validation, technical file construction, design dossier and qualification file requirements,...
Specialties:Medical Devices, Regulatory Affairs, cGMP Training, Quality Assurance, Medical Device Directives, Medical Device Software Validation, Process Validation, Risk Management 14971, QMS 13485, CMDCAS, 21 CFR 820, 60601, Combination Devices, 510 (k)
Company size:1-10 employees
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