Illustration medical technics

Solutions for complying with regulatory requirements

Optimal solutions for your requirements

The main challenges in the medical technology sector are presented by regulatory requirements that are prescribed by law. As a result, there is an acute need for consultancy, design and development services to generate the best possible solutions, which must also comply with the regulatory requirements.

Application lifecycle management (ALM)

Due to regulatory requirements, the key areas in the medical technology sector are application lifecycle management (a combination of designing, developing and maintaining applications throughout their entire lifecycle), comprehensive support and any necessary further development. In these areas, there is a need for new, innovative software solutions to be designed, developed and operated in an efficient way.

These solutions must also be constantly undergoing further development. From the requirements engineering phase right through to the finished application, the main focus here is on development time, costs, quality, process optimisation, improving product quality and seamless process traceability.

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.

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Comprehensive customer management – CRM, marketing, customer service and e-commerce solutions

Customer management is a process that begins with the acquisition of new clients by the external or internal sales team. It extends to include marketing via the various social media channels, professional customer support for services and products, and e-commerce solutions for the medical technology sector.

Having a customer relationship management (CRM) system that works well and is easy to use is therefore essential for the successful documentation and management of client relationships. This means that a modern CRM system is an important cornerstone. It facilitates advanced relationship marketing and the long-term maintenance of customer relationships – whether by using social media, social engagement marketing or customer portals. Consequently, a modern and functional CRM system also contributes to the success of the company.

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.

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Medical SPICE™ consultancy

In certain circumstances, a patient’s life can depend on software working well and being secure. For this reason, there are stringent regulatory requirements in this field. The medical technology sector is facing the challenge of satisfying regulations that relate to a constant flow of new issues.

Since lawmakers are always creating new requirements, there is a need for the best possible processes and procedures, which must also take into account the integration of all regulatory requirements – for example, those of IEC 62304. There are, however, other important aspects, which include managing the development time, cost, quality and seamless process traceability of the development process. These aspects are relevant from the requirements engineering phase right through to the finished application.

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.

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Designing and developing software solutions and apps in a regulated environment

When it comes to designing and developing professional IT solutions and apps for the medical technology sector, having experience in the area of medical technology regulations (such as IEC 62304) is a mandatory requirement – in addition to expertise in traditional project management and software development.

Accordingly, the main focus is on ensuring that the various design, development and operating processes are integrated with the regulatory requirements, such as those of IEC 62304. Furthermore, the construction, management, monitoring and documentation of an application lifecycle management (ALM) process must also be successfully implemented.

  • Standards and procedures: IEC 62366, ISO 14971, IEC 60601, ISO 13485, Medical SPICETM (VDI 5702 Part 1)
  • Technologies: Web, web apps, apps, iOS, Android, HTML 5, Java, Microsoft, AngularJS
  • Methods: IREB, ISTQB, Scrum, Kanban, agility, application lifecycle management

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.

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Successful projects - satisfied customers

We have supported companies and organizations in the healthcare sector in various projects to successfully overcome the hurdles of legislation, digitization and demanding end customers.

Do you have any questions?

Andrea Buzzi, Country Manager, is looking forward to your contact!
Phone +39 0289 736 100

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