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  • Development of Medical Device Software (MDSW)

Are you planning to develop a Medical Device Software (MDSW)?

You're in the right place. We are specialized in the development of MDSW, ensuring compliance with the Medical Device Regulation (EU) 2017/745 (MDR) and US-FDA. Our team consists of experienced software developers, regulatory affairs experts, and clinical specialists.

Our Expertise

We are specialized in developing software for medical devices, emphasizing cloud-based solutions. All our customized products meet the applicable regulations for medical devices, such as IEC 62304 or IEC 82304 standards or EC-certification and FDA approval. With our ISO 13485 certification, our products can be efficiently integrated.

Software Development for MDSW

Software Development for MDSW

Cloud Applications
Web Applications
Mobile Apps
Cybersecurity

Cybersecurity

Security Requirements
Security Architecture
Security Assessment
Data Integrity and Privacy
Technical Documentation According to MDR

Technical Documentation According to MDR including

Software Life Cycle Process IEC 62304
Risk Management Documentation
Regulatory Services

Regulatory Services

Medical Device Qualification and Classification
Implementation of MDR Requirements
Medical Device Approval
Clinical Services

Clinical Services

Clinical Evaluation
Performance Assessment
Monitoring of Clinical Data
Development of Clinical Plans
Conducting Clinical Studies & Clinical Reports

We support you throughout the product lifecycle

Our comprehensive services in medical software development according to MDR requirements cover the entire software lifecycle. From thorough requirement analysis and feasibility studies to the development of customized standalone software products and cloud-based solutions, as well as meticulous database design and implementations tailored specifically for MDSW. Additionally, we provide continuous maintenance of software products, including updates and adjustments, ensuring that your Medical Device Software always functions optimally.

What is MDSW and SaMD?

In the realm of medical technology, two terms often encountered are MDSW (Medical Device Software) and SaMD (Software as Medical Device). What are the differences and similarities of the two terms?

MDSW (Medical Device Software)

MDSW is any kind of software for medical devices either as part of a hardware medical device i.e. being the firmware or other form of control or even companion software of the hardware device. It can also be a stand-alone-software that is a medical device in its own right, running on general purpose hardware like PCs, smartphones or a cloud computing environment. MDSW is present in all kinds of medical devices from small insulin pumps to large MRI-machines. MDSW is the term used by the MDR for software systems or components of MDs and IVDs.

SaMD (Software as Medical Device)

SaMD refers to software intended to be used for medical purposes, without being part of a hardware medical device. So it is equivalent to the second case of MDSW, running on any general purpose hardware like PCs, smartphones or a cloud computing environment. Examples of SaMD include mobile health apps for tracking vital signs, diagnostic software for analysing medical images, and algorithms for predicting patient outcomes. The term SaMD was used in the context of the MDD and is not mentioned anymore in the MDR.

Customer Feedback

«ISS AG provided us with thorough insights into the complex regulatory landscape and concrete, tailored inputs for our situation and products during the development of our cybersecurity strategy. Their support was highly competent and comprehensive. Through a step-by-step approach, we were able to achieve ambitious goals in a new and still largely uncertain area.»
Stefan Römer
Head R&D Digital Solutions - Belimed AG
«ISS AG significantly contributed to the development of a complex medical diagnostic device. This included the development and implementation of algorithms for image analysis, software deployment, and other sub-projects.»
Benno Züger, PhD
Project Lead - Berner Gesundheit / Santé bernoise
«We had to evaluate our market entry opportunities in the e-Health sector within a short period of time. I was very impressed by the quality of the support. The team is highly competent, responsive, proactive, and solution-oriented.»
Head of Business Transformation
Large Insurance Company

How can we support your project?

Reach out to us and schedule a non-binding initial conversation.
We look forward to hearing from you and discussing your Medical Device Software needs.

Christoph Anderegg

Christoph Anderegg

Division Leader Digital MedTech

Contact us

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