Our team builds digital health products that can be used instead of conventional drug therapies, offering entirely new and alternative approaches to improve the quality of life for all chronic disease patients. We can act as legal manufacturers of medical devices and IVDs.
Our expertise
Our expertise
Medical device innovation with an experienced team that brings technical, quality, and regulatory expertise to support you from SaMD, and DTx digital health product ideation, up to final EU MDR, FDA, or other regulatory submission.
An accredited RA/QA partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). Our team delivers expert guidance from the initial design phase through to the final stages of commercialization, ensuring compliance with all relevant regulations and quality standards. Find out more
Our expertise lies in developing software solutions with a strong emphasis on SaMD and compliance with the strictest medical requirements. Our strategy combines technology with in-depth clinical knowledge to guarantee that every SaMD product we create is both legally compliant and produces significant health benefits. Find out more
Medical disorders are treated, managed, and prevented with specialized therapy modalities. In order to deliver evidence-based treatment interventions, each DTx product is created by fusing digital innovation with medical experience. Find out more
Our clinical affairs team oversee the development of clinical trials throughout the lifecycle of a product, from research and development through the market approval process and during post-market evaluation.
Process
Process
We are dedicated to overcoming the challenges of developing medtech solutions and providing innovative, patient-focused care. Together, we can transform healthcare by advancing the frontiers of innovation.
We work cooperatively with partners while concentrating on their business case and end consumers of the product. In order to identify unmet needs, patient and user feedback is used to lead user research and validation. A talented team approaches the human-centric design process by striking a balance between great user experience and regulatory constraints.
Regulatory expertise is required at this point to make sure every product conforms with the relevant regulations. Agile teams with a focus on native mobile, desktop, and web applications produce SaMD & DTx products. Our primary goal is quality, and we have a QMS for designing, running, launching, and sustaining software products that is accredited to ISO 13485:2016.
Services include helping to release products into various markets, taking care of the intricate legal requirements, and meeting general demands. In addition, we assist with user acquisition by navigating legal and regulatory restrictions and locating avenues for promotion.
Applications are continuously monitored for events or modifications that could affect the product. Microsoft Azure cloud environments that comply with GDPR and HIPAA regulations are used to provide hosting and monitoring services. We ensure a managed decommissioning of data and applications that includes removing medical devices from regulatory bodies listings based on the demands of our clients.
Our expertise ensures compliance with the ISO 13485:2016 medical devices standard to guarantee the highest quality of our services.
Our expertise ensures compliance with the ISO 13485:2016 medical devices standard to guarantee the highest quality of our services.