Digital Chameleon can support you and your respective clients with an experienced and competent Quality & Compliance team composed of various experts from the Pharmaceutical, Biotech and Medtech sector (Biotechnologists, Pharmacists, Medical Technologists, IT Technologists and UX / Usability engineers).
We are specialized in digitalization within the Healthcare sector and provide our clients guidance with the introduction and improvement of quality management in an agile environment within a surrounding restricted by numerous regulations. Areas of interest range from LEAN quality management systems, agile computer software validation and qualification, software as a medical device, digital healthcare apps and digital platforms up to quality and audit readiness of state-of-the-art BioTech laboratories and production facilities.
By providing our on point services we are aiming to revolutionize the approach and handling of quality relevant topics within the digital healthcare sector and thereby transform conventional static approaches related to quality management to a more agile and process optimized, mostly paperless working principle following our client´s best interest when it comes to digitalization.
Within our processes we apply profound knowledge and a deep understanding of regulations combined with standards and best practices from the Pharmaceutical, BioTech and MedTech (EU GMP, FDA, MDR), field, pioneering methods in UX /Usability & Requirement engineering and agile software development frameworks (Scrum, Kanban).
The above outlined strategy enables us to provide our clients with a customized quality management focusing on their individual needs and requirements, which facilitates them an easy and efficient navigation to the complex regulatory labyrinth. Our team of experts is willing to take on any type of issue and provide adequate solutions while collaborating closely with our clients and thereby gaining a broad and in depth understanding of the respective challenge to solve. This approach enables us to provide our clients with individual and flexible service packages, that are target- and solution oriented.
We propose solution packages for below fields:
- Quality Management and Regulatory Compliance - Data Integrity, Privacy and Information Security - Audit & Assessment Services - Agile Computer System Validation (CSV) and Software Life Cycle Management - Digital Health Solutions (SaMD, Digital Health Platform & more) - Business Analysis, Usability & Requirement Engineering - Systemic Business Coaching & Change Management
Find out more about our services: https://www.digital-chameleon.ch/