Our team builds digital health products that can be used instead of conventional drug therapies, offering entirely new and alternative approaches for all chronic disease patients. We can act as a critical supplier/subcontractor in medical devices and IVD development.
Our expertise
Our expertise
Medical device innovation with an experienced team that brings technology, quality assurance, regulatory affairs, medical affairs, product strategy, design, and business development expertise to support you from SaMD and DTx digital health product ideation up to final MHRA, EMA, FDA, or another regulatory submission.
We are trusted by medical device businesses to meet or beyond the EMA, FDA, and other regulatory agencies’ QA standards. You can navigate the procedures for product review, approval, and regulatory compliance with the support of our experience working with regulators and Notified Bodies. Read more
An accredited medical and regulatory affairs partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). We deliver expert guidance from the initial design phase to the final stages of commercialization, publication planning, and ensuring compliance with all relevant regulations. Read more
Medical disorders are treated, managed, and prevented with specialized therapy modalities. To deliver evidence-based treatment interventions, each DTx digital health product is created by fusing digital innovation with medical experience. We guarantee that every product is both legally compliant and produces significant health benefits. Read more
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, guaranteeing the highest quality of services for our partners in life sciences.
Our expertise ensures compliance with the ISO 13485:2016 medical devices standard, guaranteeing the highest quality of services for our partners in life sciences.