our approach aimed at maximizing productivity & efficiency.
modern ways of manufacturing products.
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En pellentesque magna nec libero suscipit aliquam. Vestibulum ante ipsum primis faucibus orci luctus et ultrices posuere cubilia curae; Fusce dui est, ultricies nec ultriciesa porttitor quis tellus. Sed tristique erat, ac rhoncus nisl. Mauris erat urna, egestas nec nibh ut, sagittis convallis lacun. Phasellus varius urna in scelerisque convallis. Aenean rhoncus non eros et viverra.
Industry 4.0 – the systematic approach
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predictive machines
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certified factory
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service related FAQ’s
Key standards include:
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ISO 62366-1 – Usability engineering for medical devices.
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ISO 14971 – Risk management for medical devices.
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IEC 60601-1-6 – Usability requirements for medical electrical equipment.
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ISO 20916 – Performance studies for IVDs.
Any medical device or new in vitro diagnostic medical device that is imported or manufactured for the purpose of clinical investigation, clinical performance evaluation, testing, evaluation, demonstration, or training must be kept in containers with labels clearly indicating:
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Name of the product or code number
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Batch or lot number
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Serial number (wherever applicable)
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Date of manufacture
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Use-before date
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Storage conditions
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Name and address of the manufacturer
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The specific purpose for which it has been manufactured
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“For Clinical Investigation / Evaluation Only – Not for Sale”
ISO 20916 provides the internationally recognized framework for good clinical practice in the design, conduct, and reporting of clinical performance studies using specimens from human subjects.
Based on the number of models and varients the timeline may change. usually the timeline for class B is approx 8-10 montsh and Class D is 14 months.
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
