ENGINEERS OF
DIGITALIZATION

Medical Software Development and Solutions

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Faster Time to Market for Your Medical Device or Application

Are you looking to bring a medical device or software to the market with full confidence in its quality and compliance? As an ISO 13485 certified partner, we specialize in the development of medical software that is not only reliable but also aligned with US quality and regulatory requirements.

LEARN MORE ABOUT OUR EXPERTIZE

Expert Software Development and Solutions for Medical Devices

In the highly regulated US healthcare landscape, the path from a medical software idea to market entry demands compliance with rigorous standards, stringent regulations, and unwavering attention to detail.

At Atostek, we specialize in medical device software development. We pride ourselves on our deep understanding of FDA regulations and our commitment to compliance with US quality and safety standards.

Our team specializes in delivering advanced software services and solutions that not only align with but surpass the rigorous requirements of the medical device industry. We ensure that our clients’ medical devices achieve market clearance efficiently and without compromise to patient safety.

Software Development Process

The software development process for medical devices typically progresses according to the following stages. You can see an example of workload estimates in the picture below.

The picture includes steps from the beginning, but the project can also be initiated at later stages. Often, the product is ready for the market at stage 5 (Minimum Viable Product).

PET ERP – Enterprise Resource Planning for PET Centers

Is it difficult to schedule academic research and diagnostic PET studies at the same time? Are you searching for a solution to efficiently schedule a large number of PET scanners and tracers? With PET ERP, you can streamline your PET centre’s operational processes, data traceability and tracking.

Can the risk of disease be predicted? Pfizer’s and Atostek’s research studies the potential of Kanta data for the automated identification of disease risks

In the study funded by Pfizer, Atostek studied whether the risk of contracting a disease caused by pneumococcus could be predicted by utilizing Kanta data.

EU vs. US medical device regulations and quality management: Understanding the key differences

What are the main differences between the EU and US approaches to Quality Management Systems in the medical device industry?

Medical software development – how does it differ from other software development?

Medical software development differs in many ways from other types of software development. These differences include usability and risk management from a patient safety perspective. What else needs to be considered?

PULSEON

“Atostek had a ready quality management system for medical devices. It is very important for us that we can trust the product they deliver is done with a good quality and the paper work is done as it should.”

Jaakko Hattula, CTO

ANSWERS NEUROSCIENCE

Barry Kosofsky, Founder

MYNDSPAN

“Through our collaborative efforts with Atostek, we have succeeded in creating a new kind of solution for monitoring the human brain. The cooperation has gone smoothly and the solid expertise of Atostek’s medical software has played a decisive role throughout the project.”

Janne Huhtala, CEO

REVENIO

Atostek developed software and productised the Matlab-based calculation method for Revenio’s Ventica asthma diagnosis product. Work included developing web-based service for initializing, performing and reporting the measurements and developing the communication method between USB-connected measurement device and web service.

OUR OTHER INDUSTRIES

Agile information systems are key tools in improving the quality of healthcare and social services, enhancing operational efficiency, and ensuring patient safety.

Non-Road Mobile Machinery

We develop high-quality software solutions for autonomous machines, along with specialized software designed to meet your specific needs.

Industrial Applications

Are you developing intelligent software that adds value to the end user of your product? Do you need high-performance systems to make your production more efficient?

Software Engineering

Your business has individual needs – whether you require software as part of your product, for internal processes, quality assurance, or production, our software engineering expertise is designed to meet your unique requirements.

Secondary Use of Health Data

Better quality and cost savings through secondary use of health data — Atostek has years of experience in managing data in the health and social services sector, and in the utilization of Kanta data.

AI and Data

Are you looking for ways to improve quality and increase productivity in your business? Do you want to make better, data-driven decisions and shape your company’s vision for the future?

Machine Vision Applications

Are you looking for a machine vision solution to meet your business needs? Machine vision can be used to improve the quality of goods and services, streamline processes and develop new innovative products.

Consulting and Training

Are you creating or updating your company’s digital strategy? Are you planning to implement a major system or need help with feasibility assessment?

PET ERP

PET ERP is a comprehensive Enterprise Resource Planning system for PET imaging. With PET ERP, you can streamline your PET centre’s operational processes, data traceability and tracking.