Tomorrow's Medical device software

In a rapidly emerging Medtech and IVD industry, software has become a vital component for breakthrough advances. With the challenge of ever-changing regulations, we offer a key to finding a practical and pragmatic way to navigate the various requirements placed on market players today - our way of contributing to tomorrow's breakthrough products with patient safety and benefit in focus.

developing the technologies of tomorrow

We understand the importance of embracing the future of technology in the medical device sector. Our focus is on guiding you through regulatory developments through medical device software expertise. Whether you strive to optimize your technical documentation, want guidance on how to develop products that are compliant with the latest requirements, ensure cybersecurity or navigate the Notified Body application process, our offering is designed to meet your unique needs.

Our expertise spans key areas such as risk management (ISO 14971, IEC TR 80002-1), usability (IEC 62366), system lifecycle (IEC 62304) and product lifecycle safety (IEC 81001-5-1) for Medical Device Software (MDSW). We support you not only in meeting the requirements, but also in optimizing safety and performance throughout the product lifecycle.

Services in Medical device software

Software development for Regulatory Compliance
We offer services to optimize your software documentation and processes to ensure full compliance with the latest medical device regulations. From the application process to Notified Body audits, we tailor solutions to meet your unique requirements and ensure regulatory compliance.
Strategies for cybersecurity
Explore our specialized solutions to integrate robust cybersecurity measures into your medical device software. We offer customized strategies and conduct risk analysis to protect your software infrastructure and ensure data integrity.
Life cycle management
We offer solutions to manage the entire life cycle of medical device software, with a particular focus on meeting the requirements of IEC 62304. From strategic planning and development to implementation and maintenance, we ensure that your software complies with medical device standards.
Risk management, usability and system life cycle
We provide comprehensive risk management, usability and system lifecycle solutions for MDSW. By integrating robust risk management strategies, optimizing the user experience and managing the entire lifecycle of your medical device software, we ensure compliance and high performance through every phase of development.
AI-driven Innovation: Tailor-made solutions
We tailor our services to ensure that your software is compliant with current regulations and maintains the highest standards in AI-driven medical technology.
Compliance Partner
A Compliance Partner is just what it sounds like - customised expert reinforcement that helps you with exactly what you need, when you need it. With no full-time contracts or commitment periods, our specialists support you as advisors, experts or operational support whenever you need an extra hand or brain.

Book a free workshop

How well do you control your software work? Get things moving in the right direction! Book a free TWO-HOUR WORKSHOP with our software specialists. Whether you are looking to optimize your technical documentation, want guidance on how to develop products that are compliant with the latest requirements, ensure cybersecurity or navigate the Notified Body application process, our offer is designed to meet your unique needs. During our interactive workshop we will help you with what you need!
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Questions about Medical device software?

Contact an expert

Cecilia Fällman

Chief Sales Officer
Cecilia Fällman
Chief Sales Officer
Pascal Skoglund, Consultant at Plantvision AB Pascal Skoglund, Consultant at Plantvision AB

Pascal Skoglund

Head of Unit PVC Skåne / Health Care
Pascal Skoglund, Consultant at Plantvision AB Pascal Skoglund, Consultant at Plantvision AB
Pascal Skoglund
Head of Unit PVC Skåne / Health Care

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