Our Services
Born from a passion for sharing knowledge, Congenius built its foundations offering tailored expertise in Quality and Regulatory. The successful delivery of over 400 projects across the MedTech industry has now driven our expansion into eHealth, Operations and Clinical.
Whilst our growth in excellence areas develops, our vision remains the same; to enable the smartest route to enhanced medical solutions. Read on to find out more about our individual departments.
Quality
At Congenius, we offer in-depth knowledge that enables the optimisation of your quality processes to meet the relevant regulations and standards. Whether your challenge is related to quality management, quality engineering or quality assurance, our highly skilled Quality team can help you discover the smartest solution.
At Congenius, we offer in-depth knowledge that enables the optimisation of your quality processes to meet the relevant regulations and standards. Whether your challenge is related to quality management, quality engineering or quality assurance, our highly skilled Quality team can help you discover the smartest solution.
Regulatory
Product performance and patient safety are paramount within the MedTech and Pharmaceutical industry. We understand the importance of trustworthy advice in the regulatory field, so the knowledge we provide is steeped in experience. We can support you with regulatory strategy, technical compliance, worldwide registration, and post market surveillance activities.
Product performance and patient safety are paramount within the MedTech and Pharmaceutical industry. We understand the importance of trustworthy advice in the regulatory field, so the knowledge we provide is steeped in experience. We can support you with regulatory strategy, technical compliance, worldwide registration, and post market surveillance activities.
eHealth
The eHealth environment is fast-evolving. Committing to patient safety and cybersecurity as the top priorities, we ensure our eHealth team maintains an adaptable attitude and diverse skillset. We can help to facilitate all aspects contributing to the successful development of medical device software (including SaMD & SiMD) for physical devices, eHealth, mHealth and Digital Health.
The eHealth environment is fast-evolving. Committing to patient safety and cybersecurity as the top priorities, we ensure our eHealth team maintains an adaptable attitude and diverse skillset. We can help to facilitate all aspects contributing to the successful development of medical device software (including SaMD & SiMD) for physical devices, eHealth, mHealth and Digital Health.
Operations
The highly regulated medical devices and combination products environment demands a detailed understanding of manufacturing activities. Our Operations team offers reliable support to customers who need to ensure and optimise their operational processes.
The highly regulated medical devices and combination products environment demands a detailed understanding of manufacturing activities. Our Operations team offers reliable support to customers who need to ensure and optimise their operational processes.
Clinical
Our Clinical team provides services that cover the entire lifecycle of a compliant medical device. We offer a realistic approach and practical solutions to facilitate effective clinical strategies, and our commitment to achieving success for our customers ensures that our clinical evaluation documentation is comprehensive.
Our Clinical team provides services that cover the entire lifecycle of a compliant medical device. We offer a realistic approach and practical solutions to facilitate effective clinical strategies, and our commitment to achieving success for our customers ensures that our clinical evaluation documentation is comprehensive.
News & Knowledge
Subscribe to our monthly knowledge update