Software Development for Pharmaceutical Companies
We develop digital products for pharmaceutical companies, ranging from companion apps and digital health applications (DiGA) to complex decision support systems, all certified to ISO 13485 and ISO 27001.
As a specialized developer of medical device software, we combine software development with regulatory compliance under the MDR and the German Law on the Advertising of Medicinal Products. This allows us to turn your idea into a compliant, market-ready product.
Custom Development of Evidence-Based Software
We develop software products tailored to the needs of pharmaceutical companies.
From the initial idea to the finished product.
Marketing & Commercial
Patient support programs, educational tools, and professional community portals that guide patients and doctors throughout the entire course of treatment and bring the brand to life.
Medical Affairs
Companion apps, decision-support tools, and medical information resources that are scientifically sound, evidence-based, and vendor-neutral.
Digital & Business Development
New digital business models, such as DiGA, which are finding their way into standard care as reimbursable applications.
Our Services for Pharmaceutical Companies
We support pharmaceutical companies in these areas. In addition, we develop other products tailored to your specific needs.
Companion Apps & Real World Evidence
Apps that support therapy while systematically collecting real-world care data on treatment progress, symptoms, and quality of life. This real-world evidence supports indications expansions, reimbursement, and scientific publications.
DiGA (App on Prescription)
A prescription-based and reimbursable application that is being integrated into standard care as a digital complement to drug therapy. We have already been involved in the development of more than 15 DiGA projects.
→ Our DiGA Development Service
Decision Support Systeme for Doctors
Software that supports diagnostic and treatment decisions and identifies suitable patients in healthcare data. Particularly valuable for rare and underdiagnosed diseases.
→ Our Services for Clinical Decision Support Systems
Diagnostic & Educational Tools
Symptom checkers, risk assessments, and doctor finders that help patients get the right diagnosis and find the appropriate specialist more quickly. Product-neutral information that improves care for a specific condition.
Patient Support Programs
Companion apps that provide training, reminders, and usage guidance for a specific medication, helping to improve treatment adherence. This enhances treatment outcomes, especially for complex specialty therapies.
Professional Portals for Doctors
Secure platforms for medical information, scientific exchange, and services. They enable well-informed, cross-channel communication with healthcare professionals.
From Concept to Compliant Product
We support you throughout your product’s entire life cycle, from the initial idea to ongoing operations.
1. Strategy & Concept
We’ll work with you to determine the target audience, medical purpose, and regulatory classification. This initial step determines whether your product is a medical device and what requirements it must meet.
2. Design & Planning
We design applications that are easy for patients and healthcare professionals to understand and use, and we incorporate architecture, data protection, and security into our planning from the very beginning.
3. MDR-compliant Development
If the product is a medical device subject to the MDR or FDA (U.S.) regulations: We develop and document it in accordance with IEC 62304, ISO 13485, and all relevant standards.
4. Launch & Support
We assist with market launch, regulatory approval, and operations, and support you with maintenance, further development, and compliance with post-market obligations.
From Concept to Compliant Product
We support you throughout your product’s entire life cycle, from the initial idea to ongoing operations.
1. Strategy & Concept
We’ll work with you to determine the target audience, medical purpose, and regulatory classification. This initial step determines whether your product is a medical device and what requirements it must meet.
2. Design & Planning
We design applications that are easy for patients and healthcare professionals to understand and use, and we incorporate architecture, data protection, and security into our planning from the very beginning.
3. MDR-compliant Development
If the product is a medical device subject to the MDR or FDA regulations: We develop and document it in accordance with IEC 62304, ISO 13485, and all relevant standards.
4. Launch & Support
We assist with market launch, regulatory approval, and operations, and support you with maintenance, further development, and compliance with post-market obligations.
QuickBird Medical Case Study
Telemedicine Communication Platform
Advanced Therapy Medicinal Products (ATMPs) open up innovative possibilities for the treatment of rare and severe diseases. As a development partner, we have collaborated with Heidelberg University Hospital to develop a telemedicine platform that directly connects hospitals, treating physicians, and patients, and consolidates data from hospital information systems, registries, and medical practices. The project, which received 13.6 million euros in funding from the G-BA’s Innovation Fund, brings together 24 German university hospitals, the Techniker Krankenkasse, professional associations, and patient representatives.
ORIKO®
First Digital Health Application (DiGA) for Adults with ADHD
ORIKO® is a digital health application (DiGA) for adults with attention-deficit/hyperactivity disorder (ADHD). The app offers a 12-week guided therapy program that provides medically sound information and supports those affected in their daily lives—evidence-based, digital, and tailored to the needs of the target group.
Pharmaceutical Software: What Is Permitted?
When does our software become a medical device?
Software used solely for information, reminders, or scheduling is generally not considered a medical device. As soon as software collects and analyzes medical data or supports medical decisions, it becomes a medical device under the MDR. This depends on the intended use of your product. We’ve written a detailed guide to help you break down this decision in a structured way: Go to the guide
As a pharmaceutical company, are we allowed to offer an app directly to patients?
Yes. Patient-focused applications are a well-established format for pharmaceutical companies, for example, to provide information about diseases, support treatment, or offer indication-specific services. The specific design depends on the product concept and the regulatory framework, particularly the advertising regulations for prescription drugs. We take these requirements into account as early as the conceptual phase and design the application so that it is regulatory-compliant and avoids gray areas from the outset. For pharmaceutical companies, this legal certainty is of central importance. Accordingly, we implement all regulatory requirements consistently and with the utmost care.
Can a pharmaceutical company offer a digital health application (DiGA)?
Yes. The DiGA Regulation does not exclude any specific companies. The key criteria are CE marking, data protection, interoperability, and a proven positive impact on patient care. We can advise you on the right model and handle the technical and regulatory implementation.
Does QuickBird Medical also handle regulatory compliance and assume regulatory responsibility?
Yes, we can assume the role of distributor under the MDR for medical device software and thereby assume the legal responsibilities of the manufacturer, allowing you to focus on sales and marketing. Learn more about this service here: Legal Manufacturer for Medical Device Software
What really sets us apart
ISO 13485 certified
Our quality management system is certified to ISO 13485. This ensures that we develop software as a medical device in compliance with regulations and meet the requirements of the MDR and the FDA (21 CFR, QMSR) for quality management systems.
ISO 27001 certified
QuickBird Medical is ISO 27001 certified for information security. We are experts in cybersecurity and in handling sensitive health data in compliance with data protection regulations, whether through penetration tests, security audits, or the design of your security architecture.
External Placing on the Market
If necessary, we can act as the legal manufacturer for your medical device software. We therefore bear legal responsibility for compliance with all regulatory requirements of the MDR. This allows you to focus on your core competencies, such as sales and marketing.
Are you Planning to Develop a Digital Product in the Pharmaceutical Industry?
Our team will assist you with the planning, design, and technical and regulatory implementation of your application. Contact us to schedule a no-obligation initial meeting.