Additional important operations that must be successfully implemented in the field of medical technology include the integration of regulatory requirements (such as IEC 62304) and the management, monitoring and documentation of the entire application lifecycle management process. The sector must grapple with agile development models, such as Scrum, which pose a particular challenge. An additional task is to successfully ensure compliance with the new Medical SPICE™ standard (VDI 5702 Part 1).

Our expertise for your application lifecycle management solution

We advise you on the build process and on the further development and optimisation of a comprehensive (and, if sensible and desired, agile) application lifecycle management solution that is in line with IEC 62304. We can also provide support in the form of CodeBeamer, a suitable partner solution from Intland Software, and we can provide the relevant ready-made templates for IEC 62304 and the like. This approach facilitates comprehensive compliance with the requirements of the new Medical SPICE™ standard (VDI 5702 Part 1).

You can benefit from our numerous years of industry experience and our expertise. We have already helped well-known clients and SMEs in the medical technology sector by successfully building agile solutions and by integrating appropriate tools, for example. We would be glad to speak to you in person and provide you with detailed references.

Yet existing CRM systems often fail to meet all of the desired requirements. Consequently, it is not possible to guarantee top quality customer support for certain services and products for the B2B and B2C sector. Furthermore, it is not possible to embed the technical specifics of medical technology into existing CRM solutions, which means that carrying out the modernisation and optimisation work becomes a matter of urgency.

We support you in designing your processes

adesso advises you about the processes that need to be created and also assists you with the implementation and adaptation of your processes. We offer you our services as a proficient partner. We have a wealth of experience at our fingertips, which includes work with sector-specific solutions and projects relating to customer relationship management, marketing, customer service and e-commerce. We also have close partnerships with the market leaders in these areas (such as Microsoft and SAP), who offer both cloud and on-premises solutions. We would be glad to speak to you in person and provide you with detailed references.

We support you in designing your processes

Accordingly, consultancy that is based on Medical SPICE™ (VDI 5702 Part 1) and that relates to the best way of designing solutions that conform to IEC 62304 and other relevant standards (such as IEC 62366, ISO 14971, IEC 60601 and ISO 13485) provides an important cornerstone for the medical technology sector.

We advise our clients in the medical technology sector about the best approach to building software and we help them to design regulatory processes that conform to the new Medical SPICE™ standard (VDI 5702 Part 1). Where required, we combine our consultancy services with a comprehensive (and, if desired, agile) application lifecycle management solution, along with the relevant templates to facilitate quick and efficient implementation.

You can benefit from our numerous years of active involvement in the standardisation committees concerning Medical SPICE™. adesso’s Life Science division has already successfully passed Medical SPICE™ audits. Our extensive practical experience in this sector includes areas such as agile application lifecycle management processes and the integration of appropriate tools at well-known clients and SMEs in the medical technology sector. We would be glad to speak to you in person and provide you with detailed references.

The medical technology sector also faces the challenge of making use of new development models (such as Scrum). It must do so in order to ensure that the design and development of IT solutions is efficient in terms of development time, cost and quality, while also taking into account all of the regulatory requirements. Design and development tasks still have to be outsourced due to strained resources or lack of available capacity, skills and expertise.

We offer expert assistance with the design and development of professional IT solutions

Our adesso quality promise also offers you an additional assurance: Even once the warranty period has ended, we will correct any defects in software developed by us free of charge for ten years following acceptance of the service provided. This high standard of quality is highlighted by certifications, which also provide transparency regarding our work processes and the continuous improvement of these processes. Within the medical technology sector, our competencies cover the following standarts and certifications: IREB (Platinum), ISTQB, PITPM, Scrum, Medical SPICETM (IEC 62304, IEC 62366, ISO 14971, IEC 60601, ISO 13485), application lifecycle management (ALM) with tool support, ISO 9001 and ISO 27001 (information security).

Within the regulated environment of medical technology, adesso offers a very wide range of technologies and provides you with a variety of ways to approach your projects, for example, using the V-model or an agile/Scrum approach. Furthermore, you can choose from various types of contract, such as a contract that is based on time and materials, a fixed price contract or performance-related remuneration.

We would be glad to speak to you in person and provide you with detailed references.