Shaping the Regulatory Future Together

Metecon is a consulting and service provider for manufacturers of medical devices and in-vitro diagnostic medical devices.

Since 1999, we have been supporting companies with regulatory, clinical, technical, and quality-related tasks throughout the entire product life cycle. Our range of services extends from strategic consulting and market access to technical documentation, quality management, and clinical affairs, as well as software regulation, post-market surveillance, and regulatory digitalization.

Metecon works with manufacturers of medical devices and in-vitro diagnostic medical devices. This includes established medical technology companies as well as growing companies, software developers, and organizations that are developing new products, markets, or regulatory frameworks.

Depending on the specific challenge, we support individual departments, interdisciplinary project teams, or senior management. In doing so, we take into account the respective product landscape, organizational structure, and strategic starting point.

Metecon supports manufacturers in areas such as regulatory strategies, EU conformity assessment, international approvals, quality management systems, technical documentation, risk management, clinical and performance evidence, and post-market surveillance.

Other key areas of focus include medical device software, cybersecurity, AI regulation, software validation, and the digitalization of regulatory processes.

Since these tasks are often interrelated, we also take into account the interfaces and impacts on related disciplines.

Metecon combines technical expertise with a holistic view of products, processes, and organization.

We do not treat regulatory tasks as separate, isolated services. Depending on the issue at hand, we bring together expertise from regulatory affairs, quality management, clinical affairs, the natural sciences, engineering, software, and digitalization.

In doing so, we not only provide advice but also support our clients through the actual implementation. Our goal is a solution that is technically sound, fits the organization, and can be sustained over the long term.

To begin with, we clarify the initial situation, the specific issue at hand, existing dependencies, and the desired outcome. Building on this, we work together to define responsibilities, work packages, and the appropriate approach.

Depending on your needs, we take on individual tasks, supplement internal teams, or support comprehensive regulatory projects. Throughout our collaboration, we ensure that decisions and their rationale are transparent and that relevant knowledge is not confined to just a few individuals.

Yes. Metecon supports manufacturers in digitizing regulatory processes and information.

To do this, we analyze existing processes, responsibilities, data structures, and system landscapes. We guide companies through the development of their target vision, the selection of suitable tools, implementation, and the optimization of digital workflows.

Our focus is not on individual systems. What matters most is that processes, data, roles, and regulatory requirements work together consistently. Our consulting services are vendor-neutral and tailored to the specific requirements and structures of each company.

A new tool can perpetuate existing problems in the digital realm if processes, responsibilities, and data structures have not been sufficiently clarified beforehand.

Regulatory digitalization therefore begins with the question of how information should be created, reviewed, approved, used, and maintained throughout the product life cycle. Only then do requirements for workflows, data models, interfaces, and systems emerge.

Metecon combines this organizational and regulatory perspective with the selection and implementation of suitable digital solutions.

You don’t need to be able to assign your question to a specific service area or person just yet.

Briefly describe your current situation and your goal. We’ll then connect you with the experts whose experience best matches your regulatory, clinical, technical, or digital needs.