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Support Our Clients
to Achieve Regulatory Approvals

DKNSB provides Consulting Services for Medical Device Industry

Support Our Clients
to Achieve Regulatory Approvals

DKNSB provides Documents Drafting Services for Medical Device Industry

Support Our Clients
to Achieve Regulatory Approvals

DKNSB Provide Facility Designing Services for Medical Devices Manufacturers

More about DKNSB

Best domain experts

Each wing of our entity is led by the best domain experts that create value in Regulatory Compliance

How can we support you achieve Regulatory Approvals?

We focus on providing services in realistic time frame and cost effectively.

Get in touch

Call us at: +91-98711-93930
Write to us at: info@dknsb.in

Compulsory Registration in India for All Foreign and Indian Medical Device Manufacturers
Effective From 1st October 2021, Every Foreign Company, Indian Importer and Indian Manufacturer who sells in India or wishes to sell Medical Devices in India, must have Compulsory Registration

Import Registration

In Order to Sell the Medical Devices Manufactured Outside India, there is a need to have Import Registration with CDSCO.

CE Marking

We have Experienced and Enthusiastic Professionals that support your organization to get CE Certification

Quality Assurance

ISO Certification-13485:2016 / EN ISO 13485:2016, MDSAP. Our Experienced & Enthusiastic Team of Professionals can support

Manufacturing License

Our Experienced and Enthusiastic Team of Professionals can support your organization to get Manufacturing License

US FDA Approval

The US FDA has classified the Medical Devices as Class 1 devices, Class 2 devices and Class 3 devices

Regulatory Software & Services

Medical Device manufacturer companies have to create and maintain the UDI

Facility Designing

We have Experienced and Enthusiastic Professionals that support your organization to get CE Certification

Document Drafting

We at DKNSB provide you Technical Document Service of Risk Analysis as per ISO 14971:2019, Clinical Evaluation

Objective

Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers of Medical Devices.

Achievements

DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.

Goal

Regulatory Support to our clients in enhancing their Global Presence.

Connect With DKNSB

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    Get in Touch With Us.

    Interested in working with us? we’re always happy to chat.

    For Inquiries: +91-98711-93930.

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