Gentian Health
Gentian Health is a fully integrated electro-mechanical medical device design and manufacturing partner, committed to delivering innovative healthcare solutions. Founded in 2007 and based in Shannon, Ireland, the company specializes in designing, engineering, and manufacturing medical devices and connected health products. With a focus on quality, regulatory compliance, and client collaboration, Gentian Health supports the entire product development journey from concept to clinical trial batches and commercial production. The company is certified to ISO 13485, ISO 9001, and FDA registered, ensuring high standards and global compliance.
Industries
Nr. of Employees
small (1-50)
Gentian Health
Products
Class II wearable vital signs monitor (case study)
Sensor-based, Class II wearable device for monitoring vital signs, developed as part of connected wearable device projects and intended for clinical evaluation.
Smart wound care proof-of-concept
Proof-of-concept development for wearable smart wound care devices integrating sensors and connectivity for monitoring applications.
Breath analysis instrument (case study)
Complex electro-mechanical breath analysis system combining sensors, custom electronics and mechanical subsystems for analytical applications.
Endoscopic camera and surgical device projects
Design and manufacture projects for endoscopic and surgical devices, including miniaturised imaging concepts for endoscopy and Class II surgical instrument development.
Catheter-based drainage and home-care device project
Development of a patient-centric catheter-based drainage solution intended to enable home management, active fluid control and remote monitoring for patients with pleural effusions.
Compression device for chemotherapy-induced hair loss (research project)
Research and development of a portable, compression-based device designed to reduce chemotherapy exposure to hair follicles without relying on cryogenic cooling.
Class II wearable vital signs monitor (case study)
Sensor-based, Class II wearable device for monitoring vital signs, developed as part of connected wearable device projects and intended for clinical evaluation.
Smart wound care proof-of-concept
Proof-of-concept development for wearable smart wound care devices integrating sensors and connectivity for monitoring applications.
Breath analysis instrument (case study)
Complex electro-mechanical breath analysis system combining sensors, custom electronics and mechanical subsystems for analytical applications.
Endoscopic camera and surgical device projects
Design and manufacture projects for endoscopic and surgical devices, including miniaturised imaging concepts for endoscopy and Class II surgical instrument development.
Catheter-based drainage and home-care device project
Development of a patient-centric catheter-based drainage solution intended to enable home management, active fluid control and remote monitoring for patients with pleural effusions.
Compression device for chemotherapy-induced hair loss (research project)
Research and development of a portable, compression-based device designed to reduce chemotherapy exposure to hair follicles without relying on cryogenic cooling.
Services
End-to-end medical device design
Product and system design services from requirements gathering, human factors, proof-of-concept, prototyping, industrial design and integration of mechanical and electronic systems.
Embedded electronics and firmware development
Electronic architecture, PCB schematic and layout, firmware to EN 62304, sensor integration and communications stack development for wearable and connected devices.
Medical device manufacturing and assembly
In-house PCBA, box-build assembly, configurable assembly cells, functional testing, cleanroom assembly (ISO 7) and sterile packaging for clinical and commercial batches.
Regulatory, quality and compliance support
Quality management and regulatory engineering services including ISO 13485 system implementation, technical file preparation for CE and FDA submissions (510(k), De Novo) and other territory certifications.
Design verification & validation and documentation
Provision of V&V activities, Design History File, Device Master Records and process validation documentation to support clinical trials and regulatory submissions.
Collaborative research and consortium partnerships
Participation in multi-partner research and commercialisation consortia to develop advanced medical device concepts, optics and nano-manufacturing projects, and patient-centric medical solutions.
End-to-end medical device design
Product and system design services from requirements gathering, human factors, proof-of-concept, prototyping, industrial design and integration of mechanical and electronic systems.
Embedded electronics and firmware development
Electronic architecture, PCB schematic and layout, firmware to EN 62304, sensor integration and communications stack development for wearable and connected devices.
Medical device manufacturing and assembly
In-house PCBA, box-build assembly, configurable assembly cells, functional testing, cleanroom assembly (ISO 7) and sterile packaging for clinical and commercial batches.
Regulatory, quality and compliance support
Quality management and regulatory engineering services including ISO 13485 system implementation, technical file preparation for CE and FDA submissions (510(k), De Novo) and other territory certifications.
Design verification & validation and documentation
Provision of V&V activities, Design History File, Device Master Records and process validation documentation to support clinical trials and regulatory submissions.
Collaborative research and consortium partnerships
Participation in multi-partner research and commercialisation consortia to develop advanced medical device concepts, optics and nano-manufacturing projects, and patient-centric medical solutions.
Expertise Areas
- Medical device design
- Connected and wearable health devices
- Electro-mechanical systems integration
- PCBA and electronic manufacturing
Key Technologies
- Bluetooth
- LoRa
- Wi‑Fi
- Cellular/GSM