Meeting regulatory compliance:
Software development for pharma & medical device companies
New business opportunities, faster product launches and better patient services are all part of the new digital reality. To take full advantage of this, pharma and medical device companies must also become software companies. In such a highly regulated industry this pivotal shift in direction can leave a company exposed, caught in between the new and old. At Data Ductus we help you bridge this gap.
A standard-based approach to software engineering
Meeting regulatory compliance can be one of the most difficult areas of an IT software project in the pharmaceutical and medical device industry, especially if you don’t have the right competencies on your team.
Our core team of software engineers not only excel at development but are also well acquainted with the regulatory landscape and how it impacts software engineering practices.
When you choose to work with Data Ductus, you get high quality, standard-conformant code, in accordance with:
Case studies and articles
The European Parliament has set forth new regulatory requirements for post-market surveillance (PMS). The current In…
A leading provider of medical equipment serving hospitals, clinics, and laboratories within diagnostics, in both human…
As a leading provider of clinical trial software, PCG Solutions needed to extend their software capabilities. We…
Faster time-to-market with regulatory compliant software
Using standards-based code at an early stage of development means projects aren’t delayed by costly and lengthy verification and validation processes. This significantly speeds up regulatory approval and time to market.
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.
Choose the consultancy model to meet your software needs
Our team of experienced IT consultants bring a quality-by-design mindset to every project, no matter the scope or time frame. This includes anything from project-based consultancy work to taking over the entire application life cycle management of your pharmaceutical / medtech software.
- R&D as a Service: We drive software development on behalf of your organisation. With a 360 perspective, we plan, develop and deploy solutions, and define the roadmap moving forward in close collaboration with your team.
- Application Lifecycle Management: We take responsibility for continuous product or component and deliver 3rd line support.
- Projects: Hand-over projects to our off-site development team. We manage the project, delivery and onboarding. Can be anything from a product feature to a complete product solution.
- Consultants: Hire individual software consultants or small development teams that can take part at start-up or in ongoing projects onsite or remotely.
The life science application lifecycle management approach
Our application lifecycle management approach ensures life science software is developed with your long-term strategic goals, while meeting current KPIs and SLAs. It supports agile working methods, iterative development and promotes proactive product maintenance.
A core team of experienced consultants
Our core life science team includes developers, testers and project managers. As well as their experience from working with standards and attending educational courses, they are also accustomed to following in-house governance systems and internal regulatory processes.
The IEC 62304 medical device life cycle process covers:
Smooth onboarding and transition
Smooth onboarding and transition are essential for life science companies that already have a software solution but want to outsource management and future development. Our two-phase process ensures we have a full understanding of your software, product offering and upcoming roadmap. It ensures clear lines of collaboration and responsibilities are defined between our team and your product owner, that the scope of delivery is agreed upon, and that SLAs and KPIs are set.
Beyond medical device software
Partnering with Data Ductus brings benefits beyond your immediate software engineering challenge. With a broad IT offering we can help you take full advantage of today’s infrastructures from both a strategic and practical perspective, assisting you with such things as:
- When and when not to use cloud services
- Handling multi-tenancy challenges when customers interact directly with cloud services
- Compliance and regulations when deploying services in new environments
- Managing and tracking IoT data
- Automating services across and within networks
- Securing sensitive data
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