Labfront and Rook Quality Systems have forged this partnership to bridge the gap between health research and market-ready medical devices

BOSTON, MA, U.S.A., July 5, 2023/EINPresswire.com/ -- Labfront, a global startup at the forefront of data-driven health research, and Rook Quality Systems (RookQS), a leading consulting firm specializing in digital therapeutics and Software as a Medical Device (SaMD), have entered into a strategic partnership. This collaboration aims to empower researchers to bring their innovative ideas to the marketplace, transforming them into fully realized, market-ready products.

Labfront is revolutionizing health research with its unique code-free digital biomarker collection and analytics solution. Their unique platform allows researchers to efficiently and simply process complex data from a multitude of sources, primarily wearables, reducing both the barrier to entry and the cost of research projects.

RookQS, with its deep experience and knowledge of Software Development Lifecycle Processes, FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity, makes an ideal partner to assist researchers in navigating the complex regulatory landscape. Their expertise ensures that these pioneering health products not only meet but exceed regulatory standards in terms of quality and reliability.

As part of the partnership, all paid Labfront accounts will now come with a complimentary 30-minute consultation for Software as a Medical Device (SaMD) offered by RookQS's seasoned product development, quality, and regulatory experts with a deep technical background. This combination will accelerate the pace of taking innovative ideas to market while also improving the quality of end products and reducing costs.

"Research shouldn't just stay in labs," said Chris Peng, CEO of Labfront. “By partnering with RookQS, we are bridging the gap between research and marketable medical devices. Our customers will now receive the regulatory guidance they need, while also having the tools to leverage their data effectively. It's a win-win situation."

Andrew Wu, General Manager of RookQS’ Taiwan Branch, added, “Applications of research findings are vital to improving healthcare systems. Offering free consultations to Labfront's researchers allows us to take a small step toward transforming their research into tangible products. The potential of this partnership is tremendous. We have found success supporting technologies spun off from university labs and helped the researchers secure medical device certifications in the major markets."

This collaboration strengthens Labfront's commitment to supporting the scientific community's transition to real-world data and progress in the field of health research. Researchers now have a streamlined pathway to productize their inventions, with the advanced data analytics support from Labfront and the critical product development, quality, and regulatory guidance from RookQS.

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ABOUT LABFRONT
Labfront is a global startup specializing in health data analytics. It is currently disrupting academic health research through its Labfront platform, a code-free digital biomarker collection, and analytics solution. With the recent explosion of sensors in the scientific community, Labfront is helping health researchers process the overwhelming amount of complex data and transition to a data-rich future. Learn more at labfront.com

ABOUT ROOK QUALITY SYSTEMS
Since 2012, Rook has been dedicated to supporting medical device companies develop and maintain effective and efficient quality management systems in sync with the on-going engineering development activities. Our mission is to enable our clients to implement the Quality Management Systems (QMS) according to their progressive engineering milestones to ensure that they can efficiently produce effective and reliable medical devices at different stages of development. We build these 'right-sized' QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.

Rook specializes in Quality and Regulatory strategies for early-stage medical device clientele, providing expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Rook works with a wide range of devices, including class I-III devices, SaMD, and IVD, collaborating with your team on a holistic approach to getting your device to market as efficiently as possible. To learn more, visit us online at rookqs.com/case-studies.

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Labfront Media Team
Labfront
media@labfront.com

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