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.
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.
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.
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.
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
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