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Reliable and High Assurance Medical Software Development

FDA & IEC 62304 compliant software solutions

OakLabs develops premium software solutions for the life sciences sector on a variety of technology platforms. For every piece of our custom software, we constantly strive to deliver superior quality.

The Hurdles Associated with FDA and IEC Regulatory Norms

The journey for a medical device from development to market success can be a long and arduous path. The level of restrictions and regulations worldwide may prove daunting and challenging to hurdle, not just for devices, but also for integrated and standalone software programs as well. Therefore, before embarking on the development process for medical devices and software, it is vital to remain aware of laws, guidelines and standards involved, for example compliance with the IEC 62304. This regulation is currently regarded as the overarching standard for the development of medical software in Europe and is also recognized in the US by the FDA.

  • Need guidance to adhere to strict regulatory guidelines in place?
  • Want to cut down on time and expenses spent on your software development?
  • Finding it difficult to keep track of the specific demands for your device or software?
  • Looking to unlock your full achievement potential?
  • Do you want a partner who can help trace a viable path towards your goals?
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The OakLabs Method For Smooth and Reliable Software Development

Here at OakLabs, we have fine-tuned our approach to medical software development in order to provide you with the proper infrastructure, processes and procedures to help you achieve optimal results. Our experienced team can assist in identifying the exact specifications for your medical device software by thoroughly analyzing your specific requirements and offering a tailored solution that will fit your needs.

Combining our uniquely rigorous quality assurance with the employment of several industry-standard testing tools, we are sure to deliver reliable and consistent custom software with superior quality and integrity.

IEC 62304 Compliant Software Solutions for Your CDx / MDx Assay

We will develop the software for your medical device in C++, which enables us to use the same code for all major operating systems (Windows, MacOS, Linux). Hence, there is absolutely no overhead with respect to regulatory documentation or software updates during the entire life cycle of the software. We may use your existing data analysis code written in Python, PHP, R, and many more to ultimately translate into C++. Furthermore, we master various high-performance concepts like CUDA, OpenMP, and OpenCL for your computationally intense projects. From primary biomarker insights to final compliant diagnosis software for your inevitably FDA-cleared diagnostic assay, our professionals’ superior multidisciplinary expertise results in a clear and comprehensive package from start to finish.

Despite the rigorously enforced regulations at hand, our team will be able to identify and implement the most vital requirements quickly and reliably. You may benefit from our ability to develop diagnostic assays as well as any number of the diverse software development services that we offer, making us an ideal partner for companies in various fields of business.

Developmental Specifications Flexible to Your Timeline

From our fully equipped headquarters near Berlin, Germany, we begin the intricate process of software development from the thorough analysis of all necessary stakeholder requirements. We take these necessities very seriously and will go to lengths to make sure the list is completely exhaustive, addressing all qualifications.

Once the aforementioned regulatory requirements are taken into account, the theoretical work in estimating the essential software architecture of the application is a natural next step. The iterative and incremental development part of the software development cycle starts as the application is split conceptually into separated components. These components should interact smoothly and, once combined together, form the application itself.

Dev Process

Your input will be carefully and thoughtfully received during every step of the development process, making a general overview of the application which meets all guidelines. Our talented team of code writers are the muscle behind the operation, implementing the specifications and writing the code which will build your software. Each component will be subject to rigorous individual integration tests to ensure that the components are communicating properly. This will be performed at regular intervals.

Once any corrections are applied and everything is running as expected, the application itself or the application update can be released.

Do you have questions or want to discuss your specific software development needs?

Your Benefits, in Summation

A very good statistical analysis is crucial in diagnostics.
With OakLabs we have found an excellent partner supporting our ideas and improving the statistics significantly by using more appropriate and sophisticated statistical models.
The team is very experienced, knowledgeable and helpful. I can strongly recommend OakLabs and I’m also looking forward to work with them on future projects.
Dr. Patrick Scotton
Predemtec AG
Allschwil, Switzerland
IEC 62304 compliant software
quality assured
custom tailored to your needs
perfect track record