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Medical device development environments
Our experts can help you build a compliant, yet agile development environment that supports modern medical device development—from initial concept to release and maintenance.
Medical device development environment services
Development and documentation environment for medical devices
Medical device development is a highly regulated process, driven by MDR/FDA requirements and numerous international standards. At Aurevia, we help you build a structured, compliant and flexible environment for Medical Device (MD) and Software as a Medical Device (SaMD) development—from initial concept to release and lifecycle maintenance.
Agile, yet compliant development environment
Looking for an easy-to-use, cost-effective, and compliant development environment?
We design and implement MD/SaMD development environments, with years of experience working with medical device manufacturers and university-based development teams. The system supports project management, product development, and technical documentation.
Electronic development environment for product lifecycle management
Our development environment is an electronic system that enables manufacturers to manage product development projects from idea to release and maintenance in a single system.
The environment is designed especially for medical device software development (SaMD; IEC 62304), but it can also be tailored to support the development of physical medical devices.
Our solution is built on Atlassian Jira and Confluence—ensuring a scalable, cost-efficient, and well-supported platform.
A compliant development and documentation environment
The development environment supports compliance with EN ISO 13485:2016, IEC/EN 62304:2006 and EN ISO 14971:2019.
It also enables:
- Requirements management
- Risk management
- Testing
- Full traceability
- Change management
- User and role management
The environment also provides documentation support, such as:
- Compliant document approval workflows
- Comprehensive document templates for the entire technical file, when needed.
Book a free demo of the development environment
We deliver the development environment as a project, ensuring that the fully customized system remains in your ownership.
If you are looking for a versatile, automated and cost-effective solution, contact us to book a free demo.
We can also implement an electronic Quality Management System (eQMS) solution on the same platform.
Meet our expert
Miikka Kurunlahti, Systems Specialist
Meet with me to discuss your needs or get a free demo of the development environment.
Explore our quality and regulatory services
Regulatory strategy
We help you develop an efficient regulatory strategy to meet applicable regulations, mitigate risks, and accelerate time-to-market for your medical device.
Market registrations
Let our team of experts support market registrations of your medical devices in the EU, US and other markets.
Digital health and cybersecurity
Dedicated regulatory and quality experts to help you streamline your medical software development and ensure that you adhere to local and global regulations.
Technical documentation
Expert support in planning, preparing and updating your technical documentation to help you ensure compliance with applicable regulations.
Clinical evaluation
Proven expertise in planning and conducting a thorough clinical evaluation that supports the regulatory approval of your medical device.
Performance evaluation
Dedicated experts in planning and conducting a thorough performance evaluation that supports the regulatory approval of your IVD medical device.
Biological evaluation
We support you in planning and conducting a thorough biological evaluation of your medical device that is compliant with ISO 10993-1.
Risk management
Medical device risk management services for setting up and maintaining your risk management process and helping you prepare your documentation.
Usability engineering
Support for your usability engineering activities, from creating a process to preparing a usability engineering file for your medical device.
Due diligence
Quality and regulatory experts ready to support your due diligence projects with comprehensive appraisals of medical device businesses.
Person Responsible for Regulatory Compliance (PRRC)
Our experts can support you in understanding the full range of PRRC responsibilities.
Quality management system services
QMS services for medical device manufacturers to help you design, implement and manage your QMS to support your organization's needs.
US FDA QMSR
Expert guidance on the US FDA's QMSR and other US regulatory requirements to help medical device manufacturers successfully enter the US market.
Auditing services
Improve your quality management system with our internal auditing services for medical device manufacturers.
Post market surveillance
Post market surveillance services to help you systematically gather and analyze data on the quality, performance, and safety of your medical device.
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.