our approach aimed at maximizing productivity & efficiency.
modern ways of manufacturing products.
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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
Yes. Under EU MDR 2017/745, PMCF is a mandatory and ongoing activity for all CE-marked medical devices, regardless of risk class. The extent of PMCF activities may vary depending on the device’s risk profile, clinical history, and available data.
Foreign manufactures and exporters interested in selling medical devices in the USA can approach us. Our extensive knowledge of FDA regulations will aid in a smooth and efficient registration process. We the US Agents awake and answer any time when authorities ask for information. In addition to our US office, we have offices in Germany, India, Malaysia, UK and Vietnam.
We are not just like others, we have a big team of device experts, consultants and project managers who can handle any type of service to your organization.
The US Agent Service is vital for FDA medical device registration of foreign medical and in-vitro diagnostic devices manufacturers and initial exporters.
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.
All medical device manufacturers intending to sell devices in the EU, including Class I, IIa, IIb, and III must comply with the MDR.
All medical devices sold in England, Scotland, and Wales must be UKCA certified unless CE marked under special transition rules (valid until mid-2028 for some devices)
