Services at a glance
Project Management
Our Project Management experts help you plan, execute, and deliver projects successfully. Whether you prefer agile methodologies or need to manage complex programs – we have the perfect project managers for you.
Scrum Master: Supporting agile teams in the implementation of development projects according to Scrum principles. More…
SAFe RTE (Release Train Engineer): Experts for the coordination and management of agile release trains in large organisations. More…
Project Manager: Management of projects in the medical devices and pharmaceutical sector with a focus on adherence to deadlines, quality, and cost control. More…
Program Manager: Management and coordination of several interrelated projects in order to achieve strategic corporate goals. More…
Process Management
Optimized processes are the key to greater efficiency and productivity. Our Process Managers help you streamline and digitize workflows in both development and production.
Process Manager in development: improvement of development processes, introduction of lean principles and agile methods for more efficient product development. More…
Process Manager in production: optimisation of production processes, implementation of lean manufacturing and Six Sigma. More…
Digitalisation of processes: Support with the introduction of digital tools and processes to automate and improve workflows. More…
Development
Our development engineers cover the full spectrum of product development in the medical technology and pharmaceutical sectors – from requirements analysis to end-product verification.
Requirements Manager: Specialized experts who ensure that all customer and product requirements are precisely recorded and implemented. More…
Software Developer: Experts in the development of medical software, taking into account industry-specific requirements and regulations. More…
Software Architect: Specialists who design and optimize complex software architectures for medical technology products. More…
Cybersecurity Experts: Professionals who specialise in protecting medical devices, networks and data. They help with the implementation of cybersecurity strategies, the risk assessment of IT security vulnerabilities and compliance with relevant regulations such as IEC 62304 or the MDR. More…
Design Engineer: Technical specialists who are focussed on the construction and design of medical devices and components. More…
Structural Engineers: Engineers who carry out structural calculations for the safety and functionality of medical devices. More…
Verification Engineer: Specialists in the verification and validation of products to ensure compliance with all regulatory requirements. More…
Quality & Regulatory Affairs
In the medical devices and pharmaceutical industries, quality and regulatory compliance are paramount. Our experts ensure your company meets the highest standards.
ISO 13485 Quality Manager: Experts in quality management systems who ensure that your products meet the requirements of ISO 13485. More…
Manager Regulatory Affairs: Specialists who ensure that your products fulfil all regulatory requirements in the markets in which you operate (MDR, FDA, etc.). More…
Risk Managers: Experts who identify and assess potential risks in development processes, production and regulatory matters. They create and implement risk management plans in accordance with ISO 14971 and other international standards to ensure product and patient safety. More…
Do you have any questions or would you like to find out more about our services?
Do not hesitate to contact us. Together we will shape the future of your company and set new standards for your success.
Scrum Master
Challenge:
The realisation of agile development projects in medical technology requires not only technical knowledge, but also excellent coordination between interdisciplinary teams. The challenge lies in ensuring efficiency and quality while complying with industry-specific standards.
Our solution from experienced specialists:
An experienced Scrum Master in medical technology knows the regulatory requirements and has in-depth knowledge of agile methods. He/she promotes the self-organisation of the teams and ensures that processes run efficiently in order to optimise development cycles and ensure compliance with standards.
Support and integration:
Our Scrum Masters are supported by our specialist department and optimally integrated into your projects. This allows them to work productively straight away and be seamlessly integrated into existing teams to ensure targeted and smooth project implementation.
Your benefits as a manager in medical technology:
With an experienced Scrum Master, you gain agile project implementation characterised by adherence to deadlines and high quality. You benefit from increased efficiency, improved team cohesion and successful compliance with all regulatory requirements.
SAFe RTE (Release Train Engineer)
Challenge:
Managing and coordinating agile release trains in large medical technology companies requires precision and comprehensive expertise. It is crucial to synchronise teams across departments and ensure compliance.
Our solution from experienced specialists:
Our release train engineers are experienced in managing large projects and have in-depth knowledge of the SAFe methodology. They coordinate agile release trains and ensure that all teams work towards a common goal and that the regulatory requirements of medical technology and pharmaceuticals are met.
Support and integration:
The RTEs are comprehensively supported by our specialist department and optimally integrated into your project environment to enable close collaboration and rapid project adjustments.
Your benefits as a manager in medical technology:
As a manager, you benefit from the smooth running of large, agile programmes. Our RTEs ensure timely, efficient delivery and support compliance with all specifications, enabling you to implement your programme in a transparent and controlled manner.
Project Manager
Challenge:
Projects in medical technology and pharmaceuticals require precise time and cost planning, the highest quality standards and compliance with regulatory requirements. The challenges here are high, especially when several departments need to be coordinated.
Our solution from experienced specialists:
Our project managers specialise in managing complex projects and have detailed knowledge of standards such as ISO 13485 and FDA requirements. They focus on quality and adherence to deadlines and ensure compliance with all legal and regulatory requirements.
Support and integration:
Our project managers are optimally integrated into your existing structures and supported by our team to relieve your internal resources and ensure swift, smooth project implementation.
Your benefits as a manager in medical technology:
With our project managers, you will win projects that are completed on time, on budget and to a high quality. This ensures your company’s success and fulfils all regulatory requirements at the same time.
Program Manager
Challenge:
Managing several interrelated projects requires coordinated implementation that takes strategic corporate goals into account and ensures harmonised project results.
Our solution through experienced specialists:
Our programme managers have the necessary experience to manage complex project portfolios in the medical technology sector and incorporate regulatory requirements. They set priorities and manage the projects in line with your corporate objectives.
Support and integration:
Our programme managers will be closely integrated into your existing structure and supported by our experts to ensure a smooth process and minimise the risk of delays.
Your benefits as a manager in medical technology:
Benefit from overarching project management that promotes your corporate strategy, designs processes efficiently and leads the entire project network to a successful conclusion.
Process Manager in development
Challenge:
Designing development processes efficiently while at the same time fulfilling regulatory requirements is essential in medical technology. This is where lean principles and agile methods come into play.
Our solution from experienced specialists:
Our process managers optimise development processes using lean and agile methods, resulting in shorter development cycles and increased product quality. In doing so, they take into account the specific regulatory requirements of the industry.
Support and integration:
Process managers receive comprehensive support and are integrated into your existing processes to ensure rapid and targeted process optimisation.
Your benefits as a manager in medical technology:
You benefit from lean, optimised development processes that enable you to bring innovative products to market faster and in high quality.
Process Manager in production
The challenge:
Efficient production processes are crucial for reducing costs and ensuring the highest quality. The implementation of Lean Manufacturing and Six Sigma represents a significant advantage here.
Our solution by experienced specialists:
Our process managers implement lean manufacturing and Six Sigma methods and optimise production processes for increased productivity. They reduce waste and improve efficiency in production.
Support and integration:
Our specialists are optimally integrated and comprehensively supported to continuously improve your production and smoothly implement process optimisations.
Your benefits as a manager in medical technology:
Thanks to optimised production processes, you benefit from greater efficiency and productivity with consistent quality, which has a positive impact on your market position.
Digitalisation of processes
The challenge:
The digitalisation of processes is necessary in medical technology in order to automate workflows and increase efficiency. This requires the right selection and implementation of digital tools.
Our solution from experienced specialists:
Our experts support you in the introduction of digital tools that optimise workflows and give you a better overview of the entire production process. This allows you to increase the efficiency and flexibility of your workflows.
Support and integration:
We integrate our specialists seamlessly into your organisation to implement digital solutions with a perfect fit and support your employees throughout the entire process.
Your benefits as a manager in medical technology:
The digitalisation of processes enables you to improve transparency, increase efficiency and adapt more quickly to market changes. This strengthens your competitive position and reduces operating costs in the long term.
Requirements Manager
Challenge:
In medical technology, the precise recording and implementation of customer and product requirements is crucial, as even minor deviations can lead to significant quality or compliance problems.
Our solution from experienced specialists:
Our requirements managers specialise in systematically capturing complex customer requirements and translating them into clearly defined project steps. They ensure that all requirements are clearly documented and that all regulatory requirements are taken into account.
Support and integration:
The requirements manager is specifically integrated into your development processes and continuously supported by our team to ensure smooth collaboration and guarantee the quality of the requirements.
Your benefits as a manager in medical technology:
With a specialised requirements manager, you minimise the risk of misunderstandings and ensure that products precisely meet the specifications – for efficient and standard-compliant product development.
Software Developer
Challenge:
The development of medical software requires specialised knowledge of medical technology standards and high safety standards. Software products must fulfil the regulatory requirements of the industry and offer the highest quality and safety.
Our solution from experienced specialists:
Our software developers have extensive experience in developing software for medical technology. They work in accordance with standards such as IEC 62304 and ensure compliance with all safety standards in order to develop high-quality and safe solutions.
Support and integration:
The software developer will receive comprehensive support from our team and will be optimally integrated into your IT and development structures to ensure seamless and productive collaboration.
Your benefit as a manager in medical technology:
By using our software developers, you ensure customised, standard-compliant software solutions that meet both regulatory requirements and the specific needs of your users.
Software Architect
Challenge:
The planning and optimisation of complex software architectures in medical technology requires not only technical expertise, but also a deep understanding of industry-specific requirements and standards.
Our solution from experienced specialists:
Our software architects are experienced in developing stable and scalable architectures that meet the stringent requirements of medical technology. They ensure that all safety and quality-related aspects are taken into account right from the design phase.
Support and integration:
Our software architects are seamlessly integrated into your development projects and comprehensively supported by our team in order to be productive immediately and optimise your software development.
Your benefits as a medical technology manager:
With an experienced software architect, you benefit from future-proof software solutions that both meet safety standards and offer a high degree of flexibility for future enhancements.
Cybersecurity experts
The challenge:
The security of medical devices and networks is essential in medical technology. Cybersecurity threats can jeopardise patient safety and must be effectively defended against.
Our solution from experienced specialists:
Our cybersecurity experts specialise in protecting medical devices and data. They implement security strategies and fulfil regulatory requirements, such as IEC 62304 and MDR, to ensure maximum security for your products.
Support and integration:
The cybersecurity experts are optimally integrated into your IT and security processes and supported by our team to ensure efficient collaboration and proactively close security gaps.
Your benefits as a manager in medical technology:
With a cybersecurity expert, you secure your products and data against attacks and protect the integrity and security of your medical devices and networks.
Design Engineer
Challenge:
The construction and design of medical devices require precise technical realisation and a deep understanding of the requirements for functionality and user-friendliness.
Our solution by experienced specialists:
Our design engineers develop innovative and reliable designs for medical devices that meet the highest standards of functionality and quality. They know the specific requirements of medical technology and ensure a smooth transition to production.
Support and integration:
Our design engineers are integrated into your projects and receive continuous support to ensure smooth collaboration with your teams and efficient product development.
Your benefits as a manager in medical technology:
With a specialised design engineer, you will increase the efficiency of product development and ensure that your products meet market and user requirements.
Structural engineer
Challenge:
The design of medical devices requires precise structural calculations to ensure the safety and stability of the products, especially in critical applications.
Our solution by experienced specialists:
Our structural engineers perform comprehensive calculations and simulations to ensure that your products can withstand stress and meet all safety requirements.
Support and integration:
The structural engineers are supported by our team and seamlessly integrated into your design processes to ensure fast and effective handling of structural requirements.
Your benefit as a manager in medical technology:
With a structural engineer, you ensure the safety and functionality of your products, minimise risks and meet the highest medical technology standards.
Verification Engineer
Challenge:
Verification and validation of medical devices is crucial to ensure that all regulatory requirements are met and product safety is guaranteed.
Our solution by experienced specialists:
Our verification engineers specialise in the validation and verification of medical technology products and ensure that all tests comply with regulatory requirements. They carry out comprehensive tests and document them in accordance with standards.
Support and integration:
Our verification engineers are supported by our team and optimally integrated into your test processes to ensure efficient and smooth implementation of the tests.
Your benefit as a manager in medical technology:
The expertise of our verification engineers ensures that your products meet the highest quality and safety standards, which strengthens the reliability and market acceptance of your products.
Quality Manager ISO 13485
Challenge:
Compliance with the ISO 13485 quality management standard is essential in medical technology to ensure product quality and regulatory conformity.
Our solution from experienced specialists:
Our quality managers are experts in implementing and maintaining quality management systems in accordance with ISO 13485, ensuring compliance with standards and continuously optimising processes.
Support and integration:
The quality manager is comprehensively integrated into your quality processes and supported by our specialist department to ensure efficient implementation and standard-compliant documentation.
Your benefits as a manager in medical technology:
By employing an ISO 13485 quality manager, you ensure high product quality and reduce the risk of regulatory violations.
Manager Regulatory Affairs
The challenge:
Compliance with international regulations is crucial for the market access of medical technology products. Regulatory affairs management requires a deep understanding of MDR, FDA and other regulatory requirements.
Our solution from experienced specialists:
Our regulatory affairs managers will guide you safely through the entire market authorisation process and ensure compliance with all relevant regulations. They navigate through the regulatory requirements and provide support for authorisation in various markets.
Support and integration:
The Regulatory Affairs Managers are supervised by our team and integrated into your projects to enable rapid and targeted processing of all regulatory requirements.
Your benefit as a manager in medical technology:
With an experienced Regulatory Affairs Manager, you minimise the risk of delays in the approval process and ensure that your products reach the market quickly and in compliance with regulations.
Risk Manager
Challenge:
In medical technology, risk management is of central importance to ensure product safety and compliance with ISO 14971.
Our solution from experienced specialists:
Our risk managers identify and assess potential risks in the development and production processes. They create risk management plans and ensure that all safety requirements are met to guarantee product and patient safety.
Support and integration:
Our risk managers are optimally integrated into your processes and supported by our team to ensure efficient risk management.
Your benefit as a manager in medical technology:
With an experienced risk manager, you ensure the safety and compliance of your products and minimise the risk for your company and your patients.