The impact of digitalization can be felt across every industry, none more so than in healthcare, pharma and medical device companies. Thanks to technological advancements, we no longer have to rely on reactive data, connectivity is automated, proactive data is collected and analyzed, and patients are treated faster and more reliably. However, all this relies on an effective medical software development.
This puts big demands on the industry. Organizations now have to combine excellence in medical research and/or patient treatment with excellence in medical software. This means actors also need to have an extensive understanding of the strict and ever-changing regulatory demands that their solutions are subject to.
Don’t be held back by technology
The technology advancements that should speed up innovation, can be the one thing that holds a medical company’s progress back if they don’t have the right software expertise. Building a complete inhouse team is challenging, expensive and can be inflexible. Bringing in qualified and experienced experts to support a core team is often the best and simplest way forward.
Digital roadmap development
Planning the digital future of your organization and products is a major task. Made even harder if you aren’t up to date with the latest tech capabilities, expert service providers, or upcoming regulations. Even if you are fully up to date, you must get leadership buy-in for your plans.
Our experts can collaborate and support you with all the necessary information for an investment decision during your project initialization and project charter stage:
- Budget requirements
- Potential ROI
- Timelines and initial Work Breakdown Structure
- Project Risk
- Quality and Compliance Risk, i.e., IVDR 2022 and EU MDR 2024
- Stakeholder definition
- Procurement and development plan
We identify the optimal platform, identify the ideal service providers and define resource requirements – to minimize the risks. Final delivery is an achievable and value adding digital roadmap.
If you require any further information, feel free to contact us
Ensure data integrity
Meeting regulatory compliance is a major challenge for any software used in the pharmaceutical and medical device industry. Ensuring data integrity is central to this. If it’s not done correctly, it can result in hold-ups to releases and even major fines.
And it’s not getting any easier, since 2016 there has been a major increase in the number of FDA warning letters that a company can receive. These include:
- “Failed to maintain complete data from all laboratory tests conducted to ensure compliance with established API specifications”
- “Raw data were discarded and therefore not available”
- “Fail to retain basic chromatographic information such as, injection sequence”
- “Analytical data were deleted and overwritten”
The FDA is now including recommendations for recipients of such letters to obtain 3rd party assistance when addressing data integrity issues. Which is where we can support you.
We carry out a gap analysis, including a review of your architecture, to see where improvements should be made. Based on this, we can help you plan the actions your IT teams need to take to secure data and ensure its integrity, through the implementation of regulations such as FDA 21 CFA, Part 11 and MHRA Data Integrity Guidelines and ISPE GAMP 5, among others.
We also offer software training in this area to bring your team up to speed with the latest regulatory requirements.
Implementation services Deployment services
Compliant-ready medical software development
Ideally, data integrity and other regulatory requirements will be coded into software from the outset to avoid lengthy and costly verification and validation processes. For those organizations that don’t have the inhouse capability to do this, we can provide this service. Applying agile and DevOps methodologies, we develop standard-conformant code to meet the regulatory frameworks that your services must adhere to in order to speed-up regulatory approval and time to market.
Our consultants can play a key role as part of your software development team. In this highly collaborative set-up, one or several Data Ductus experts form a key part of your IT organization ensuring software delivers on your vision.
We develop life science software in accordance with EU, FDA, USDA and MHRA regulations including MDD 93/42/EEC (now replaced by 2017/745) and FDA Title 21 CFR Part 11.
Make regulatory-compliant software a priority
Find out more about our expert software engineering services
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Medical cloud migration and management
Migrating to the cloud is a complex process that can quickly escalate beyond budget expectations without meeting the expected performance requirements. Tasks can often be solved in multiple ways but depending on which you choose the outcome of performance vs cost efficiency can be very different.
Migration is much more than just moving data because what works on-premises may be very different in the cloud. Expert guidance can help you avoid pitfalls and ensure a successful cloud migration/deployment. Our experience from delivering medival software development and supporting medical companies to transition to the cloud means we can help pinpoint the right tools and methods to meet your short and long-term needs. Our cloud experts can support you with:
- Assessment of your medical cloud requirements and development of a migration roadmap.
- Migration of operations and services to a secure cloud/hybrid solution
- Monitoring, support and scaling of cloud applications
To find out how we can help you migrate to the cloud contact us
+46 910 73 23 21