Medical Devices

DQR team provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR, FDA related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.
We bring your Medical Device (Implantable, Non-Implantable), Single Use, Implants, Software (SaMD), Borderline Drug-Device combination, wearable, and IVD products to the market and keep it there, by advising on “go to market strategy” & drafting documents needed for 510(k) clearances, DeNovo, PMA approval, CE Marking, ISO 13485, MDR compliance & more. DQR offers an end-to-end solution for companies in the field of:

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What we offer to MedTech Industry

Product

Companies often get busy with product development and miss on the critical activity of documentation. DQR MedTech team always help by working side by side of your design team and drafting, reviewing, and updating:

Regulatory

DQR MedTech is the industry leader in driving successful regulatory submissions and outcomes through effective, daily interactions with the USFDA, CDSCO, TGA, Taiwan, Invima, Japan’s PMDA, Europe’s Notified Bodies, China’s NMPA and other international authorities.
We provide a wide range of regulatory services across the full spectrum of product design and development through post-market support. From Notified Body selection and Pre-IDE preparation to Advisory Panel Meetings, our experts develop and implement global regulatory strategies to accelerate your specific commercialization efforts—ultimately getting you to market faster so you may make a more immediate impact on patient safety and healthcare.

Clinical

The requirement of sufficient qualitative and quantitative clinical evidence is mandatory to demonstrate the device safety and performance throughout the life cycle of devices. Amongst the various clinical services that DQR MedTech has assisted with, the following have been the most important ones:

Quality

The criticality of the development, implementation, adherence, and continuous improvement of a compliant Quality Management System (QMS) cannot be overstated. Not only are these key processes in driving company value, but more importantly, they help ensure patient safety and the delivery of high-quality products to those that need them most. Amongst the various premarket and post-market quality systems support that DQR MedTech has provided, the following have been the most popular ones:

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