SiMD - Software IN a medical device (SiMD) means that the software is part of another medical device and helps it function in some way.
Medical device software development refers to the process of planning, designing, developing, and testing software applications intended for use in or as medical devices
Whether you are a MedTech startup seeking your first FDA approval, a mid-sized company going digital, or a leading medical device manufacturer looking to outsource your engineering needs, we have you covered. Our medical device software development services are ISO 13485 and IEC 62304 compliant and backed by over 15 years of experience in the healthcare industry. We rely on proven software architecture and project management practices to design and build secure, MDR- and FDA-cleared SaMDs and SiMDs.
SaMD - Software AS a medical device (SaMD) means that the software itself is the device.
Our tailored approach
We enjoy working on projects in the medical field with a quality-driven approach to medical device software development. Our track record includes diagnostic devices, health monitors, and C-classified medical devices such as a 6D patient positioning system under a linear accelerator, providing quality- focused software development and testing.
Our team can work alongside existing in-house teams or be your provider of the full engineering service stack for medical NPD. If needed, we can conduct a skills gap analysis and recommend a suitable team to fill those gaps.
We also have a verification and validation team that can integrate with your larger multidisciplinary team. If required, we can work with clients to explore the creation of a custom automated test solution.
Our compliant process
Our ISO 9001 certified QMS is aligned with ISO 13485, but does not have said certification. We made a conscious decision to do this in order to take full advantage of the Agile software development methodology. For our medical device customers, we ensure that our processes meet the requirements of ISO 13485, which has been confirmed several times by second party audits conducted by our clients. What you get is a development team following your QMS instead of their own.
Whether your product requires EU or FDA approval, we have a harmonized and compliant approach to both.
Case examples
-
Image guided 6D positioning
One of the obstacles to achieving accuracy in the delivery of radiation therapy is patient positioning under linear accelerator. While modern 3D volume imaging can remove uncertainties arising from organ motion, it takes patient positioning system to complete the IGRT localization chain by enabling accurate and remote geometric correction of any discrepancies observed.
Our challenge was to design and implement control and user software which can drive the robotic patient positioning system and achieve sub-millimeter 6D conformal positioning accuracy, thereby allowing clinicians to reduce margins with confidence, escalate dose and move towards hypofractionated treatment regimes.
-
Non-invasive ICP meter
Intracranial pressure (ICP) remains a key indicator of brain health in patients with a variety of neurological conditions. Current techniques for ICP measurement involve the use of invasive monitoring, which carries a small risk of major complications. Vittamed’s noninvasive ICP meter uses transcranial doppler to measure the balance in ultrasound pulse waves of the ophthalmic artery.
Our challenge was to design and implement the software for the non-invasive intracranial pressure meter medical device along with the preparation of related DHF documents.
-
Wound care
Chronic wounds cause an amputation every 30s and affect more than 2% of the population. Healthcare system capacity is reaching a limit as patient numbers go up.
Our challenge was to co-develop robotic wound management solution which allows clinics and hospitals to expand their capacity by providing automated wound treatments in the patients’ own homes.
-
Feet thermal monitor
FeetSeeTM is HIPAA-compliant medical device for monitoring of the feet and identification of early signs of inflammation in order to prevent complications, such as diabetic foot ulcers. Feetsee technology is based on a fusion of innovative thermal hardware and software with advanced algorithms.
Our challenge was to prepare a part of the technical documentation (Design History File / Technical File) in concert with the customer’s developer team who was new to medical device software regulatory requirements of IEC 62304:2015.
Our ideal customer profile
-
Medical device manufacturers
-
Healthcare software product companies and startups
-
Pharmaceutical, biotech, and life science companies
-
Medical device manufacturers 2
Our medical software development service vs.
Contractors
Rubedos is always more cost effective. You’ll only need to onboard us as part of your procurement process, rather than recruiting and payroll. We’ll always have people available to work on your project, helping you stay on schedule. Meanwhile, a contractor, despite an average day rate of €640, still needs a team leader to keep them on track, not to mention sick leave and holidays.
In-house team
Rubedos is more cost effective in the first year and less cost effective as you build your in-house team. If you hire the right people and take care to learn how to establish good processes, it will take an in-house team 1 to 2 years to become as productive as our high-performing team. Once that happens, they’ll be a better value.
Cost saving steps
New product development process
Feasibility study
Perform a detailed feasibility study prior to starting any cost intensive phase
Rapid prototyping
Develop a rapid prototype, provided the feasability study report shows promise
Prototype validation
Use standard components whenever possible to cut corners on expensive R&D
Grade design
Make sure the prototype gets validated prior to applying design management process