Project Management for Medical Software Development

Proven Expertise in Medical Device Software Project Management

With more than 20 years of experience in software management and nearly a decade dedicated specifically to medical device software, we understand the unique challenges of this field. Our track record includes guiding multiple companies through the demanding journey of bringing certified medical devices to market under EU MDR and FDA regulations.

We have repeatedly stepped into challenging projects where regulatory requirements or documentation efforts were underestimated, aligning teams and stakeholders with a clear focus on delivering compliant, certified products.

Holistic Approach to Medical Device Project Management

We believe successful medical device software projects require more than classic project management. They call for a holistic approach that combines project management and product management, aligning strategy, execution, and compliance into one framework.

Bridging Project and Product Management

Hands-on support in product development activities where needed
Strategic oversight to anticipate bottlenecks, risks, and regulatory challenges
Alignment of project execution with company goals, market releases, and regulatory deadlines

Strategic Planning for Medical Device Projects

Balancing the triangle of scope, resources, and deadlines
Early effort assessment for critical activities such as risk management, cybersecurity, or documentation
Support in budget planning, regulatory strategy, and submission timelines

Synchronizing Development and Compliance

Integrating software development with regulatory milestones like EU MDR submissions, FDA clearance, clinical evaluations, and usability studies
Ensuring development cycles remain in sync with certification and market-entry plans
Combining Agile delivery with structured planning to meet both technical and organizational objectives

By merging these two worlds, project management and product management, we create clarity, reduce risks, and ensure that every aspect of your product and its regulatory journey is aligned for final success.

Examples of Projects We Brought to Success

Led the complete design and development of a clinical decision support tool (Class IIa), managing risk, digitalizing technical documentation, and ensuring compliance across the full product lifecycle.
Coordinated combined medical devices with hardware, software, and cloud components, aligning multiple teams and harmonizing cybersecurity, risk management, and usability documentation for FDA submission.
Established new quality management systems with design control procedures, training teams for clarity and compliance, leading to successful product releases as certified medical devices.
Supported a contract development project for a top global pharmaceutical company, aligning complex quality management systems and technical documentation between various organizations participating in the product, resulting in successful external audits.

Turning Project Complexity into Clarity

Our role goes beyond tracking deadlines or monitoring budgets. We step in as true partners, helping teams and organizations align around what really matters: delivering safe, effective, and fully compliant medical device software.

Based on our experience, the challenges are rarely just technical; they often lie at the intersections of regulation, documentation, and team collaboration. This is where we bring value.

Guidance and Teams Motivation

We help development teams understand why regulatory and documentation requirements matter, not just what needs to be done.
By connecting software development to EU MDR, FDA, cybersecurity, risk management, and post-market surveillance requirements, we create a clear picture that makes sense for everyone involved.
Teams will experience the moment of clarity where all the pieces connect, which accelerates execution and builds confidence.

Bringing Teams and Departments Together

Complex projects often involve multiple teams or even multiple companies contributing hardware, mechanics, software, and cloud solutions. Misalignments in such setups can easily lead to delays or even open conflicts between departments.
We resolve these issues by clarifying dependencies, identifying intersections, and creating alignment across all contributors, allowing the project to move forward as one.

Aligning Project Management Across Departments

Projects can appear close to completion but face serious setbacks due to missing or contradicting documentation, risk management gaps, or misaligned clinical and cybersecurity aspects.
We specialize in identifying and closing these gaps, bridging between departments, and ensuring consistency across all technical files and regulatory deliverables.
With our approach, even projects that seemed stuck have been steered back on track toward successful EU MDR certification or FDA submission.

Hands-On Expertise in Medical Software Development

We are not consultants who only work on paper. We are a software development company with decades of practical experience in building software.

That means we understand the full software lifecycle, the obstacles that appear along the way, and the realities of keeping a project on track.

Managing such projects comes naturally to us because we know what it takes—from requirements engineering and risk management to cybersecurity, maintenance, and regulatory alignment.

While we have also supported other types of medical devices, our core strength lies in software. This focus allows us to deliver the value our clients expect with the confidence that comes only from hands-on experience.

Flexible Project Management Methodologies for Medical Device Software

We have built and shaped project management processes for organizations of all sizes—from startups to some of the largest pharmaceutical and medical device manufacturers in the world. Our strength lies in adapting methodologies to fit the specific environment, ensuring compliance with IEC 62304, AAMI TIR45, and other relevant standards while keeping teams effective and aligned. We are not here to force an approach; we are here to enable your organization to succeed with the methodology that works best for you.

Traditional Approaches: Waterfall and V-Model

For organizations that prefer structure and predictability, we have successfully implemented Waterfall and V-Model approaches.
These methods provide clarity, well-defined milestones, and strong alignment with regulatory deliverables, making them suitable for projects that require strict documentation and sequential progress.

Agile Project Management in Medical Software

We have introduced Agile methodologies into medical device organizations, aligning iterative development with compliance requirements under IEC 62304 and TIR45.
Agile brings flexibility and responsiveness, while we ensure that documentation, risk management, and regulatory needs remain fully satisfied.

Hybrid and Tailored Solutions

Many projects benefit from hybrid approaches, combining the strengths of sequential models with Agile flexibility.
We design solutions that respect the needs of all stakeholders—development teams, regulatory affairs, risk management, cybersecurity, usability engineering, and clinical affairs.
Our role is to create processes that are practical, compliant, and truly workable for everyone involved.

Project Enablers, Not Enforcers

We do not push organizations into one predefined model. We adapt, create, and optimize processes to fit your team, your culture, and your product requirements. All recognized methodologies can work, when executed properly, and we make sure they work for you.

Project Management Tailored to Your Scale

We are prepared to step in where agility, speed, and close collaboration with the team are essential, just as we are ready to manage large-scale projects where alignment across departments, formal governance, and coordination at multiple levels are required.

Our experience covers both ends of the spectrum, from fast-moving startup environments to complex global organizations. Whatever the size or scope, we adapt our project management approach to fit your needs and ensure successful execution.

Questions & Answer About Medical Project Management

Q: Do you focus only on software project management, or could you also help with regulatory stuff?

A: Yes. For us, a successful project means not only the completed software but also complete technical documentation and all supporting records required for CE marking or FDA submission. Whether it is design inputs and outputs, verification and validation strategies, risk management files, or cybersecurity documentation, we deliver projects that are ready for release and fully aligned with regulatory requirements.

Q: We are using Agile development, is that fine and acceptable for the medical device industry?

Q: Can you help the team prepare technical documentation?

A: Definitely. We are not project managers who coordinate from a distance—we are hands-on contributors where needed. In smaller teams and projects, this level of involvement is often exactly what customers value most. We can support your team with the full range of activities required in the medical product lifecycle, from requirements engineering and risk management to cybersecurity, test strategies, maintenance, and post-market surveillance processes.

Q: In what language can your project management be carried out?

A: Our working languages are English and German, depending on what the customer and their team require. We know how important it can be to ease communication and build trust, and sometimes that means speaking the client’s native language. For international teams, we work seamlessly in English, as we have done many times in the past. For German-speaking teams or colleagues who prefer German, we switch fully to German. Most of our experience in the medical device industry has been gained in the German-speaking regions of Germany, Austria, and Switzerland.

Q: Can you support us with both project management and development?

A: Yes. Project management for medical device software is part of a broader set of services we provide. Whether you need an experienced project manager to lead your product or additional support to strengthen your development capacity, we can step in. Our well-organized and versatile team can cover the entire spectrum of activities required for medical device software, including hands-on software development.