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 eHealthOperations 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.

See our full Quality offering here

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.

See our full Quality offering here

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.

See our full Regulatory offering here

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.

See our full Regulatory offering here

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.

See our full eHealth offering here

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.

See our full eHealth offering here

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.

See our full Operations offering here

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.

See our full Operations offering here

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.

See our full Clinical offering here

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.

See our full Clinical offering here

News & Knowledge

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Stay informed and up to date with the latest industry news delivered direct to your inbox. By subscribing to our monthly newsletter, you will also gain access to our full range of topical content produced by our MedTech industry experts across the Quality, Regulatory, Clinical, eHealth and Operations fields.

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If you have a challenge that you think we could help with, please feel free to get in touch in a way that suits you best. We look forward to speaking with you!

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a demo

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Simply fill out your details and click “Request a demo", then a member of the team will get back to you shortly.

Alternatively, feel free to give us a call on +41 44 741 04 04 to start the conversation. We look forward to hearing from you!

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    monthly knowledge update

    Stay informed and up to date with the latest industry news delivered direct to your inbox. You can tailor your preferences to prioritise what you'd like to hear about each month; be it MedTech news headlines, fact sheet resources on the latest regulations or longer articles covering timely topics across the wider MedTech industry.

    By clicking subscribe, you are signing up to receive a monthly newsletter from us containing MedTech news, industry insights and more from Congenius. Subscribing also gives you full access to all topical content on our website. For information on how your data is managed, see our privacy policy.