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ikenreg

Making your regulatory approval simpler and faster

ikenreg is a Medical Device Regulatory consulting firm, which provides regulatory advisory & guidance exclusively for Medical Device manufacturers for their ISO 13485 quality system implementation, CE Certification and 510(k) Clearance. Our offerings include New Product Approval Support, pre-submission and post-submission support, training services, Post Approval Support, EU Medical Device Regulations (MDR), Medical Device Single Audit Program (MDSAP) and more.

            About US

We are a group of professionals with several years of experience with strong regulatory and technical experience in a wide range of medical device therapeutic areas. We see ourselves as partners in the growth of our clients. We stand by our clients in the journey of regulatory approval of their products. Our technical expertise enables us to provide the right suggestions to our clients so that they do not overdo any activities or tests, which otherwise have an impact on the time and cost of the approval process.

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Our Services

Medical Device Regulatory Consultancy and Advisory

Our Services

ISO 13485 Consultancy

ISO 13485 Certification for Medical Devices is a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet the applicable regulatory requirements

FDA 510(k) Clearance

A 510(k) submission is a type of regulatory submission made to the FDA to get clearance to legally market medical devices in the US. In a 510(k) premarket notification, substantial equivalence to a legally marketed predicate device must be demonstrated. 

CE Certification

Medical devices manufactured or traded in the EU must comply with the medical device regulation (EU) 2017/745(MDR). After successfully completing a conformity assessment procedure to the MDR, conformity is made visible by a CE mark on the medical device. 

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