AGILE AND FLEXIBLE
We are not a large corporation and can respond specifically to the needs of our customers: In SaMD development, we act in an agile, flexible, transparent and price-conscious manner!
SaMD
SaMD is the term of the hour. SaMD is the abbreviation for Software as a Medical Device. [bornholdt lee] is your expert in the development of your new software medical device in accordance with the Medical Device Regulation (MDR). Basically, a health app has to be CE certified before it becomes a digital medical device according to the MDR. [bornholdt lee] is exactly the right partner for your SaMD development!
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Hosun Lee
Product Owner, IT Expert, eHealth Specialist & Managing Director at Bornholdt Lee GmbH. Over 20 years of IT project experience and conception of numerous digital health applications
SaMD expert informs!
What is aSaMD?
SaMD is the abbreviation for Software as a Medical Device. In German, it translates as software medical device.
Software as a Medical Device (SaMD) is software that has been developed independently or in conjunction with other hardware and is primarily designed to fulfil medical purposes without being directly integrated into the hardware of a medical device.
SaMD development
The MDR requirements are fundamental for SaMD development. Thanks to the expertise [bornholdt lee] has gained in the development of digital medical devices, we know the MDR requirements and can therefore successfully design and develop your new SaMD and accompany it through the certification process. This is how your vision receives approval as a medical device.
> What sets [bornholdt lee] apart in SaMD development
We know what challenges are associated with the market launch of a medical product such as a SaMD or the establishment of a company: Drawing up a business plan, clarifying financing, checking and implementing the required regulations and requirements of various ordinances and legal bases, observing data protection guidelines and IT security, ... no new topics for the experts at [bornholdt lee]!
We have already successfully developed numerous software medical products. Therefore, we can not only support every step towards a successful SaMD with our expertise and experience, but also actively contribute to its success with our know-how! And if we can't, we have a network of (legal) experts and advisors to fall back on.
Whether at our headquarters in Hamburg or digitally throughout Germany. [bornholdt lee] is your partner for your SaMD development!
TRUSTWORTHY AND HONEST
Open and direct communication is important to us: we talk about difficult situations as well as solutions. We know the limits of IT, but also the opportunities in innovation.
IN PARTNERSHIP
We are partners for our customers and feel responsible for our customers and our customers' products from the idea to the operation.
SaMD Consulting
We are happy to support you in problem solving, idea generation, implementation of software medical products.
Bornholdt Lee GmbH specialises in the design and development of digital sustainable solutions, smart products and innovative platforms that simplify and improve lives and thereby enhance quality of life.
Digital solutions focus on mobile apps (iOS / Android; native and hybrid), web and backend services, web applications as well as voice control, augmented reality and IoT products.
Hosun Lee
Product Owner, IT Expert, eHealth Specialist, Mentor in the eHealth Network Hamburg & Managing Director at Bornholdt Lee GmbH. Over 20 years of IT project experience and conception of numerous digital health applications
What does MDR stand for?
The MDR stands for Medical Device Regulation. The MDR stands for Medical Device Regulation. It is an EU regulation that sets out the requirements and regulations for medical devices in the European Union (EU). The MDR came into force on 26 May 2017. The MDR replaced the former Medical Device Directive (MDD).
The MDR aims to improve the safety, quality and performance of medical devices. In addition, the MDR aims to ensure a high level of patient safety at the same time. The regulation applies to a wide range of products. Implants, medical devices, diagnostics, software (including SaMD) and other medical devices are covered by the MDR.
The MDR brings important changes compared to the previous directive. These include for example:
- Extended scope: The MDR applies to a wider range of products. Including certain products that were not previously explicitly classified as medical devices, such as cosmetic implants.
- Strict regulatory requirements: The MDR introduces stricter requirements for conformity assessment and clinical evaluation of medical devices. Manufacturers must demonstrate that their products meet the required levels of safety and performance.
- Improved surveillance and transparency: The MDR strengthens the surveillance of medical devices in the market through improved traceability, uniform identification systems and the establishment of a central database for medical devices (EUDAMED).
- Increased role of Notified Bodies: The MDR places greater emphasis on the role of Notified Bodies, which are designated and approved by national authorities to carry out conformity assessment of medical devices.
The MDR applies to all member states of the European Union. It brings significant changes for the medical device industry. It was developed to improve the safety and quality of medical devices. Furthermore, the MDR aims to increase consumer and user confidence in these products.
SaMD FAQ
In our SaMD FAQ we answer important questions about SaMD. From the definition to the development to many other exciting eHealth topics.
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What does the abbreviation SaMD stand for?
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SaMD is the abbreviation for Software as a Medical Device. In German, SaMD is translated as software medical device.
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How is SaMD defined?
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SaMD is the abbreviation for Software as a Medical Device. SaMD is defined as an independent medical device. This medical device fulfils medical purposes primarily through software functions. It is software developed either as a stand-alone device or as part of a larger system that performs medical functions without being physically integrated into a hardware medical device. SaMD can be used in various healthcare settings. For example, for diagnosis, treatment monitoring or disease management.
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What does the abbreviation MDR mean?
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MDR is the abbreviation for Medical Device Regulation.
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What does a SaMD development cost?
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The cost of developing a SaMD can vary greatly depending on the scale and complexity of the application. Some factors that can influence the cost are the labour time required. The number of developers, the technologies used and the integration with other systems. It is therefore difficult to give an exact price for the development of a SaMD.
For a cost calculation, make a non-binding free consultation appointment now!
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How long does a SaMD development take?
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The duration of a SaMD development can vary greatly. Here, too, the scope and complexity as well as the budget are decisive. For a more precise estimate of the duration of a SaMD development, request your health app idea here free of charge. Click here for a free consultation for the development of a SaMD.
Our eHealth references
