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The collaboration with Thermosaver started at the end of Q2-21 by establishing the regulatory strategy and pathway to CE approval. Now after a little over 6 months of dedicated and comprehensive work by the team we are very pleased to announce that the Thermosaver rescue bag is CE approved and Thermosaver AS has an MDR compliant technical file and QMS.
The product is a medical device Class I product and for Thermosaver the CE mark is a recognition of safety, quality, and compliance.
The journey has been intense, challenging, and fun. It’s great working with committed people and the collaboration with Thermosaver and other partners in this project has been great.
Ira Sharma Sankhayan, CCO Yallow Life Science.
The process has been challenging and demanding and we would never pull this off without the superb support from Yallow. Now we are ready for market introduction as a medical device.
Ketil Thorsen, CEO Thermosaver
Yallow is an ISO 13485 certified design & development partner specialized in medical and health technology. We are passionate about developing products and services that really mean something and make a difference. Together with our clients, we improve the future.
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At Yallow, we offer expertly tailored Risk Management Services for the life science and health tech industries. Our experienced team collaborates closely with clients to develop comprehensive strategies, from initial assessment to ongoing monitoring, ensuring optimal product safety and efficacy. With our proven expertise, organizations can confidently navigate challenges and achieve sustained success in today’s competitive marketplace.
At Yallow, we specialize in UDI Implementation for life science and health tech firms. Our tailored services ensure compliance with global regulations, streamlining product tracking and traceability. From planning to labeling, we guide clients through the process, ensuring accurate device identification and facilitating market access. With our expertise, organizations can enhance patient safety, improve supply chain efficiency, and meet regulatory requirements confidently.
At Yallow, our Audit Services ensure compliance with stringent regulatory requirements in life science and health technology. Our experienced team conducts comprehensive audits, assessing documentation, processes, and systems to identify improvements and mitigate risks. Whether pre-market or post-market, our thorough approach empowers organizations to maintain quality and integrity, freeing you to focus on innovation and advancing healthcare.
Harmonized standards are crucial for global trade and product safety, particularly in life science and health tech. At Yallow, we provide expert guidance on implementing these standards to streamline compliance and foster innovation. Our Regulatory Affairs Services ensure seamless alignment with requirements, enabling enhanced market access and consumer confidence. Trust us to navigate the complexities of harmonized standards, driving global progress.
At Yallow, our Regulatory Affairs Services offer thorough Gap Analysis expertise to pinpoint discrepancies between current practices and regulatory requirements in life science and health tech. With meticulous assessment and analysis, we provide actionable recommendations to ensure compliance with global regulations and industry standards, empowering organizations to proactively mitigate risks and maintain a competitive edge.
At Yallow, our Regulatory Affairs Services provide tailored Quality Management System (QMS) solutions for product safety, efficacy, and compliance in life science and health tech. We streamline processes to meet global standards and industry best practices, guiding you through documentation, training, risk management, and continuous improvement. With our QMS expertise, navigate regulations confidently, driving innovation in healthcare.
At Yallow, we prioritize regulatory compliance in life science and health technology. Our comprehensive services guide companies through laws, standards, and guidelines, ensuring full adherence. Leveraging our expertise, we offer tailored solutions ranging from audits to ongoing support, empowering proactive compliance strategies. Trust us to handle your regulatory needs effectively, freeing you to innovate and make a meaningful impact on healthcare.
Our Regulatory Strategy services offer expert guidance through the complex regulations of life science and health tech. We collaborate closely with clients to develop aligned strategic plans, leveraging global regulatory expertise to optimize pathways for approval, market access, and compliance. From initial development to post-market needs, our meticulous approach ensures proactive compliance and sustainable growth.
Our Regulatory Affairs Services offer precise Medical Device Mapping solutions for navigating life science and health tech regulations. We ensure compliance with global requirements by assessing device classification, intended use, and regulatory status across markets. With our expertise, we streamline processes, mitigate risks, and accelerate time-to-market, empowering your organization to confidently navigate regulatory challenges.
Project management is the systematic approach we employ to initiate, plan, execute, monitor, and close projects effectively and efficiently. It encompasses a range of methodologies, tools, and techniques aimed at achieving project objectives within defined constraints of time, budget, and scope while ensuring quality and stakeholder satisfaction. From defining project goals and assembling project teams to managing resources, mitigating risks, and communicating progress, project management plays a pivotal role in driving successful project outcomes. By fostering collaboration, facilitating decision-making, and promoting accountability, project management enables us to deliver projects on time, within budget, and to the satisfaction of our stakeholders, ultimately contributing to organizational success and growth.
Gap analysis is crucial for identifying discrepancies between our current state and desired goals, driving strategic decision-making and improvement initiatives. By meticulously assessing where we stand versus where we aim to be, it highlights strengths and weaknesses within our operations. Through examining performance metrics, market trends, and best practices, we understand the existing gaps and steps needed to bridge them effectively. This enables us to prioritize resources effectively, allocate investments wisely, and chart a course for sustainable growth and success. By embracing gap analysis as a continuous improvement tool, we remain agile, adaptive, and proactive in our pursuit of operational excellence.
Our eQMS enhances quality and compliance management by streamlining workflows and centralizing documents, thereby boosting productivity and efficiency. From meticulous document control to comprehensive training record management and beyond, it ensures strict regulatory compliance and fosters a culture of continuous improvement. With its intuitive user interface and collaborative features, our eQMS promotes transparency and facilitates seamless communication among teams, fostering a more cohesive work environment. Moreover, real-time data insights empower proactive decision-making and drive innovation, reaffirming our unwavering commitment to excellence in a rapidly evolving and competitive marketplace.
Under our Quality Management System (QMS), audits play a vital role in ensuring process effectiveness and compliance. Regular audits systematically evaluate QMS performance, identifying areas for improvement and ensuring adherence to quality standards. Our meticulous audit process includes comprehensive documentation reviews, observations of practices, and interviews with personnel to assess protocol adherence thoroughly. Through audits, we validate the efficacy of our QMS in meeting regulatory requirements, achieving quality objectives, and enhancing customer satisfaction. The findings of audits are carefully analyzed, and actionable recommendations are implemented to drive continuous improvement, reinforcing our unwavering commitment to operational excellence.
At Yallow, our Quality Management System (QMS) serves as the bedrock of our unwavering commitment to excellence, ensuring that all our operations consistently meet top-notch standards. Our meticulously crafted QMS framework guarantees the delivery of superior products and services through streamlined processes, robust risk management, and stringent compliance measures. With a steadfast focus on customer satisfaction, we actively solicit feedback and continuously refine our processes to enhance the customer experience. Regular audits and assessments uphold our ISO 9001 certification, affirming our dedication to quality assurance. Through our QMS, we foster a culture of excellence that reflects our enduring commitment to delivering unparalleled quality and exceeding customer expectations.
Our ISO certifications, including ISO 9001 for Quality Management Systems and ISO 14001 for Environmental Management Systems, showcase our dedication to excellence. With ISO 9001, we prioritize customer satisfaction, continuous improvement, and consistent delivery of products and services that exceed expectations. Meanwhile, ISO 14001 reflects our proactive stance on environmental management and sustainability, emphasizing resource conservation and sustainable practices. These certifications underscore our unwavering commitment to quality assurance, ensuring our products and services consistently meet the highest standards of quality, safety, and environmental responsibility. They are more than accolades; they represent our ongoing pursuit of excellence across all facets of our business.
At Yallow, prototyping serves as the catalyst for transformative advancements in the realms of life science and health technology. Our commitment to pioneering solutions drives us to offer comprehensive prototyping services tailored to the unique needs of these dynamic industries. Explore how our prototyping expertise can bring your ideas to life and propel your innovations to the next level.
At Yallow, cutting-edge camera technology converges with the realms of life science and health technology. With a steadfast commitment to excellence, we pave the way for transformative advancements in medical imaging, scientific research, and healthcare diagnostics. Explore our groundbreaking camera solutions, meticulously designed to meet the unique demands of the life science and health technology sectors.
Optical meteorology and sensing represent a cornerstone of innovation, offering unparalleled accuracy and versatility in various applications critical to advancing healthcare and biological research. At Yallow, we specialize in harnessing optical meteorology and sensing technologies to address the complex challenges facing the life science and health technology sectors. Our expertise spans a wide range of applications, from biomedical imaging and diagnostics to pharmaceutical manufacturing and biotechnology research.
In biomedical imaging, optical metrology plays a pivotal role in the development of advanced imaging systems for capturing high-resolution, three-dimensional images of biological tissues and structures. These systems enable clinicians and researchers to visualize cellular processes, detect abnormalities, and monitor disease progression with unprecedented precision.
At Yallow, we invite you to embark on a journey of exploration and discovery into the hidden realms of the microcosm. With our cutting-edge microscopy solutions, we empower researchers, scientists, and professionals across diverse fields to unlock the mysteries of the microscopic world and advance scientific knowledge in profound ways.
With our cutting-edge microscopy solutions, meticulously designed and crafted, we empower researchers, scientists, and professionals across diverse fields to delve deep into the intricate structures and phenomena of the microscopic world. It is through the lens of our advanced microscopy technologies that we unlock the mysteries and intricacies of life at its smallest scales, paving the way for groundbreaking discoveries and advancements in scientific knowledge.
Yallow specialize in the meticulous evaluation of image quality for camera prototypes and products. With a dedication to advancing imaging excellence, our lab serves as a hub for cutting-edge research and development, offering a comprehensive suite of services to meet the diverse needs of our clients. Powered by expertise and equipped with advanced technology, we are committed to providing precise and reliable assessments that drive innovation and elevate the standards of imaging performance. Step into our world of imaging expertise and discover how we can help you achieve your vision of superior image quality and clarity.
LED optics encompass a range of optical components, including lenses, reflectors, and diffusers, meticulously designed to optimize light output and efficiency. These components are tailored to specific LED configurations, allowing for precise control over beam angles, color temperature, and uniformity of illumination.
In architectural lighting, LED optics enable the creation of immersive and dynamic environments, accentuating architectural features and enhancing ambiance. In automotive lighting, LED optics contribute to safer driving experiences by providing optimal visibility and efficiency.
Optical design plays a pivotal role in advancing life science and medical technology, revolutionizing healthcare solutions with precision and innovation. From cutting-edge medical imaging systems to intricate diagnostic tools, optical design drives the development of devices that enable clinicians to make accurate diagnoses and deliver targeted treatments.
In medical imaging, optical design ensures the creation of high-resolution imaging systems such as endoscopes, microscopes, and MRI machines. These instruments provide clinicians with detailed views of internal structures, aiding in the detection of abnormalities and guiding minimally invasive procedures.
In the realm of life science and health technology, precision and accuracy are paramount. Innovations that enhance our ability to understand biological systems, diagnose diseases, and develop treatments can significantly impact healthcare outcomes. One such groundbreaking technology making waves in this domain is LiDAR (Light Detection and Ranging). Originally developed for remote sensing applications, LiDAR has found diverse applications in the life sciences, offering novel solutions for various challenges in research, diagnostics, and treatment.
LiDAR operates on the principle of emitting laser pulses and measuring the time it takes for these pulses to return after reflecting off surfaces. By calculating the distance between the source and the target, LiDAR generates highly accurate three-dimensional maps of its surroundings. Initially used in geographical surveys and self-driving cars for obstacle detection, LiDAR has evolved to serve a multitude of purposes, including those in the life sciences.