We can be your end-to-end partner for device development

Full Product Development Lifecycle
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Support for every stage, from concept and development, through to launch and operations

- Long term partnership for connected medical devices

- System development, prime contracting, end-to-end solution delivery

- Approach to address global healthcare markets

Team Collaboration and Cultural Fit
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Way of working that matches medical device vendor’s work culture

- Open, transparent communication

- Focusing on trust and relationship

- Taking shared responsibility and ownership for ultimate program success

Agile for Regulated Devices
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Compliant medical device design, development, and integration

- Compliance with core medical device development standards (IEC 62304, IEC 62366,  IEC/EN 60601-1)

- Integrated, quality-driven development environment

- Robust, agile practices for medical device development

Clinical Engagement
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Engagement with clinical stakeholders

- Understanding of clinical workflow and care pathways

- Integration with clinical systems and services

- Design of patient and clinical interactions

Multi- Technology Solution Stack
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Technology stack that covers a wide spectrum of medical devices

- Electronics and embedded, mobile, enterprise and web development

- Use of modern technology frameworks and platforms to accelerate development

- Experience in software-as-a-service deployment and operations for SaMD

Connectivity and Integration
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End-to-end connectivity framework for medical devices

- Connectivity design and back-end services

- Wide spectrum of wireless connectivity options for home and hospital settings 

- Integration with hospital information systems

- Verification for market approval and service readiness

Cyber Security
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Security by design

- Cyber security framework

- Safety, risk-based design, implementation, and verification

- On-going field monitoring

- Post-market surveillance

Regulatory Expertise
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Proven processes and procedures to design, develop, and operate connected health solutions

- Robust eQMS certified against key standards for medical device industry (ISO 13485, ISO 14971, ISO 27001)

- Process framework for global patient data privacy

- Working towards DHF and Technical File regulatory submissions

“Working with our customers is about more than technological capability. Our teams integrate with your work culture, to deliver the best possible results and experience.

Our support doesn’t stop after development either; we offer secure device services throughout engineering, manufacturing and operations. This leads to a smoother, more cost-effective process to successfully bring a product to market.”

Derek Dwyer S3CH
Derek Dwyer
Director of Strategic Programs
Case Study
Developing a connected drug delivery device and bespoke in-hospital connectivity solution

Read how S3 Connected Health designed and developed an FDA class II connected drug delivery device for use in hospital environments.

We created a bespoke solution that uses multiple connectivity options to securely transmit data from the in-hospital device to our customer, optimizing the supply chain for this medication and revolutionizing their business operating model.

Read More
Service capabilities
  • Requirements definition, software and systems architecture
  • Electronic and firmware design
  • Wireless communications and connectivity (antenna design, radio, and RF systems)
  • IEC62304 compliant medical device software design, development, and integration
  • End-to-end cybersecurity and device management
  • Development of end-to-end integrated devices, mobile apps, portals, and cloud-based solutions
  • Medical device verification and validation
Certifications and regulatory compliance
BSI-Assurance-Mark-ISO-13485
ISO 60601 Certification
IEC 62304 Certification
UL 2900 Certification