Consulting in Medical Technology Development

Benefit from our Expertise in the Medical & Healthcare sector

Flat hierarchies and short communication channels enable the individual development steps to be closely interlinked and result in particularly fast and efficient processes. Methodology and creativity enable us to avoid wrong turns and thus save time and money. Our broad experience from various industries, coupled with our expertise in medical technology, enables us to calculate costs at an early stage and minimise them through product and process optimisation.

The transfer of our expertise to you is the core of successful development for us! To ensure this, you will always be proactively informed about the project status and the details of the development. We also support you in interdisciplinary communication, including with the quality management, risk management and production planning departments. For important decisions, we prepare a decision paper and actively involve you in the process.

Our Consulting Services in the Field of Medical Technology:

Creative Innovation Workshops

One of invenio's fundamental strengths is methodical and creative product conceptualisation. To this end, we organise innovation workshops and carry them out together with our customers. We use creativity techniques such as the 6-3-5 method or the morphological box. This has resulted in numerous industrial property rights and patents, which our clients benefit from utilising.

Cybersecurity

The growing attack surface in the increasingly networked and digitalised healthcare industry and the increasing complexity of systems require a systematic approach to the cybersecurity of medical devices. We advise you on the requirements for the digital security of medical devices and develop customised cybersecurity measures.

More information about our cybersecurity consulting services

Clinical Evaluation

We are your partner for clinical affairs. We create clinical evaluation processes according to global specifications such as MDR/MEDDEV or FDA requirements and integrate them into your existing process map. As part of the clinical documentation, we create clinical evaluation plans and reports and advise you on all relevant clinical issues, e.g. post-market surveillance or complaints handling.

Usability Studies

invenio supports you in all matters relating to the usability of medical devices, also known as usability, as part of your product development or during the life cycle of a medical technology product. In addition to regulatory requirements, we also focus on all safety-related and functional issues as well as the global acceptance of the product on the market when it comes to the usability of medical devices.

More information on usability studies

Regulatory Affairs Management

In the area of regulatory affairs management, we at invenio ensure that medical devices comply with the guidelines laid down by regulatory authorities. Thanks to our experts' many years of experience, we can advise you on country-specific regulatory requirements as well as on the authorisation process and the associated documentation.

More information on our regulatory affairs management services

Risk Management

We support you during the launch of your medical device and take on the risk management in order to minimise possible product-related or design-related risks. We cover the entire spectrum of risk processes, risk management plans, risk analyses and risk management reports and provide you with comprehensive advice on the market launch of new medical devices.

More information on invenio risk management