Continuous monitoring that keeps your device safe, compliant, and competitive.
Ideas to certified medical software
Ideas to certified medical software
Explore our capabilities
Explore our capabilities
We can act as a Critical Supplier or Legal Manufacturer to develop medical software for MedTech and Pharma. Our team delivers beyond-the-pill solutions, acting as an end-to-end digital health partner, guiding SaMD, AIaMD, and SiMD innovators and founders from initial concept through regulatory launch.
We can act as a Critical Supplier or Legal Manufacturer to develop medical software for MedTech and Pharma. Our team delivers beyond-the-pill solutions, acting as an end-to-end digital health partner, guiding SaMD, AIaMD, and SiMD innovators and founders from initial concept through regulatory launch.
Patient Companions
From initial concept and user research to global launch and ongoing optimization, our end-to-end services ensure your therapy stands out in crowded markets and delivers measurable impact at every stage.
Chronic Disease Management
We guide our Pharma and MedTech clients through every stage, from initial concept and the development of regulated Software as a Medical Device (SaMD) to product launch and ongoing operations, often serving as the legal manufacturer.
Digital Therapeutics
We act as a full-lifecycle MedTech partner, handling development, management, and operation of DTx solutions. We can take on legal manufacturer responsibilities while allowing Pharma and MedTech companies to maintain commercial ownership of their products.
Wearables and Implantables
Integrating disease management solutions with wearable, implantable, and personal medical devices to maximize therapeutic and operational value, advancing patient and provider experience, optimizing therapy adherence, and enabling improved clinical outcomes and quality of life.
ISO 13485 Certified Partner
Certified by an accredited Notified Body, we combine strategy, design, and engineering talents with an integrated ISO 13485 approach to medical device and high-tech product development.
Critical Supplier or Legal Manufacturer
Through collaboration with our partners, we act as a Critical Supplier or Legal Manufacturer.
Patient Companions
From initial concept and user research to global launch and ongoing optimization, our end-to-end services ensure your therapy stands out in crowded markets and delivers measurable impact at every stage.
Chronic Disease Management
We guide our Pharma and MedTech clients through every stage, from initial concept and the development of regulated Software as a Medical Device (SaMD) to product launch and ongoing operations, often serving as the legal manufacturer.
Digital Therapeutics
We act as a full-lifecycle MedTech partner, handling development, management, and operation of DTx solutions. We can take on legal manufacturer responsibilities while allowing Pharma and MedTech companies to maintain commercial ownership of their products.
Wearables and Implantables
Integrating disease management solutions with wearable, implantable, and personal medical devices to maximize therapeutic and operational value, advancing patient and provider experience, optimizing therapy adherence, and enabling improved clinical outcomes and quality of life.
ISO 13485 Certified Partner
Certified by an accredited Notified Body, we combine strategy, design, and engineering talents with an integrated ISO 13485 approach to medical device and high-tech product development.
Critical Supplier or Legal Manufacturer
Through collaboration with our partners, we act as a Critical Supplier or Legal Manufacturer.
Expert guidance across the full medical device lifecycle
Expert guidance across the full medical device lifecycle
Whether you are a digital health startup with a promising idea or an established organization ready for the next step, we support you from concept to market in creating medical products that truly improve patient care.
Whether you are a digital health startup with a promising idea or an established organization ready for the next step, we support you from concept to market in creating medical products that truly improve patient care.
SaMD, AI Medical Device Development
Writing code is just one of many things our software engineers excel in. They work closely with our designers and embedded software engineers to choose the perfect technology stack. They also collaborate hand in hand with our quality assurance team for your project needs in compliance with safety standards. Read More
Market Access
Aura Health helps you align your solutions with clinical and market needs, create clear value propositions, map stakeholders and payers, and design go-to-market plans that include pricing, reimbursement, launch execution, and competitive positioning. With the right strategy, your medical and digital health innovations become viable, adopted, and trusted in global markets. Read More
Health Economics
We provide health economic modeling and outcomes research for digital health and medical devices. We conduct early economic modeling, budget impact, and cost-effectiveness analyses as well as uncertainty assessments to deliver robust evidence for payers, regulators, and stakeholders. Our work supports the transition of innovation from concept to adoption by proving clinical benefit, cost savings, and long-term sustainability. Read More
Intellectual Property
Our team provides end-to-end IP support. We help identify and secure patents, software, algorithms, and designs, develop robust IP strategies, and conduct Freedom to Operate analyses to reduce legal and market risks. Our team guides you through patent filing and international protection while ensuring continuous monitoring and portfolio management. With the right IP framework, your solutions gain security, credibility, and stronger market value. Read More
Regulatory Compliance
Our teams develop your products according to applicable standards to meet the medical device’s regulatory requirements. Our process speeds up the time to market and facilitates product approval by the relevant authorities. Read More
Quality Assurance
Our QA team can support your team in becoming familiar with the medical standards and the regulatory process. Our role is to analyze the standards and regulations to establish the design requirements according to the identified specifications. Read More
Clinical Evaluation
We provide end-to-end clinical evaluation services for all software-based medical devices, including health apps, SaMD, and AI-driven technologies. Our purpose is to help you prove safety, performance, and clinical benefit, before and after market entry. Read More
SaMD, AI Medical Device Development
Writing code is just one of many things our software engineers excel in. They work closely with our designers and embedded software engineers to choose the perfect technology stack. They also collaborate hand in hand with our quality assurance team for your project needs in compliance with safety standards. Read More
Market Access
Aura Health helps you align your solutions with clinical and market needs, create clear value propositions, map stakeholders and payers, and design go-to-market plans that include pricing, reimbursement, launch execution, and competitive positioning. With the right strategy, your medical and digital health innovations become viable, adopted, and trusted in global markets. Read More
Health Economics
We provide health economic modeling and outcomes research for digital health and medical devices. We conduct early economic modeling, budget impact, and cost-effectiveness analyses as well as uncertainty assessments to deliver robust evidence for payers, regulators, and stakeholders. Our work supports the transition of innovation from concept to adoption by proving clinical benefit, cost savings, and long-term sustainability. Read More
Intellectual Property
Our team provides end-to-end IP support. We help identify and secure patents, software, algorithms, and designs, develop robust IP strategies, and conduct Freedom to Operate analyses to reduce legal and market risks. Our team guides you through patent filing and international protection while ensuring continuous monitoring and portfolio management. With the right IP framework, your solutions gain security, credibility, and stronger market value. Read More
Regulatory Compliance
Our teams develop your products according to applicable standards to meet the medical device’s regulatory requirements. Our process speeds up the time to market and facilitates product approval by the relevant authorities. Read More
Quality Assurance
Our QA team can support your team in becoming familiar with the medical standards and the regulatory process. Our role is to analyze the standards and regulations to establish the design requirements according to the identified specifications. Read More
Clinical Evaluation
We provide end-to-end clinical evaluation services for all software-based medical devices, including health apps, SaMD, and AI-driven technologies. Our purpose is to help you prove safety, performance, and clinical benefit, before and after market entry. Read More
Applying one consistent process to the design and development of every medical device helps new ideas grow and keeps communication clear across your team.
Applying one consistent process to the design and development of every medical device helps new ideas grow and keeps communication clear across your team
Discover
Finding where clinical needs meet commercial opportunity.
Define
Getting requirements right for patients and regulators.
Elaborate
Building, testing, and refining the device in fast, documented cycles.
Adapt
Proving safety and performance, securing CE or FDA approval.
Launch
Launching with a clear plan for clinicians, payers and patients.
Maintain
Continuous monitoring that keeps your device safe, compliant, and competitive.
Discover
Finding where clinical needs meet commercial opportunity.
Define
Getting requirements right for patients and regulators.
Elaborate
Building, testing, and refining the device in fast, documented cycles.
Adapt
Proving safety and performance, securing CE or FDA approval.
Launch
Launching with a clear plan for clinicians, payers and patients.
Maintain
Latest news
Latest news
Insights from people building digital health every day.
Insights from people building digital health every day.
