Our solutions.

We are an enthusiatic expert team in the field of Digital Transformation in Healthcare. We are specialised in digitalisation and new technologies in regulated industries and reinvent quality & compliance management with an agile & lean approach.
Areas of tension are: lean quality management systems, agile computer software validation and qualification, software as a medical device, digital health apps and digital health platforms, as well as quality & audit readiness of ultra-modern bio-tech laboratories and production facilities

Quality Management & Regulatory Compliance 

Data Integrity, Privacy and Information Security

Audit & Assessment Services

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Systemic Business Coaching & Change Management


Agile Computer System Validation (CSV) and Software Life Cycle Management

Digital Health Solutions (SaMD, Digital Health Platforms

and more)

Business Analysis, Usability & Requirement Engineering

What are the benefits of a Digital Health Platform?

A Digital Health Platform uses software and services to capture, transmit and analyze data from connected medical devices, combination products, apps, Digital Therapeutics and Software as a Medical Device- all in compliance with security, privacy and regulatory requirements. Thus accelarating our clients digital health journey.

How do we define and implement Digital Transformation within the Health Care Industry?

The convergence of science and technology  defines a new era of healthcare. There has never been a better time to disrupt the status quo. We are helping life sciences and healthcare companies advance their capabilities and take a more holistic view of their digital strategies.