S3 Connected Health

S3 Connected Health

S3 Connected Health

Business Description:

S3 Connected Health accelerate the development of next-generation connected medical devices and digital health solutions for wearable, implantable, and in-hospital devices to improve healthcare delivery.

Their proven processes and validated tools allow them to meet the stringent regulatory requirements of medical device development, while deep domain expertise in health means they address the needs of all stakeholders, from patients and clinicians to healthcare providers and devices vendors.

No matter where your company is on its digital health journey, S3 Connected Health’s multidisciplinary team can help. From full market analysis and concept ideation, to design and development, and through to life-cycle management of industry-leading solutions.

Product and services:

– Wearable and implantable medical device development for scale-up medtech companies

– Product development for connected, in-hospital equipment

– Digital health solutions for wearable and implantable medical devices

– Digital health solutions for connected in-hospital equipment

Value proposition:

At S3 Connected Health, we accelerate development of next-generation products and create integrated digital health solutions around medical devices to collect data and improve healthcare delivery.

Our proven processes and validated tools allow us to meet the stringent regulatory requirements of medical device development, while our deep domain expertise in health means we address the needs of all stakeholders – from patients and clinicians to healthcare providers and devices vendors.

With a multidisciplinary team that includes software engineers, regulatory experts, UX specialists, medical professionals, and business analysts, we get products to market quickly, operate them efficiently, and ensure they have a meaningful impact on patient and clinician experience.

Standards and Certificates:

Certificates:

ISO 13485 Medical Devices – Quality Management

ISO 27001 Information Security Management

Compliance with following standards:

ISO 14971 Medical Device Risk Management

IEC 62304 Medical Device Software

IEC 62366-1 Medical Device Usability

IEC 82304 Health Software

ISO 60601 Medical Electrical Equipment

Regulation (EU) 2017/745 on Medical Devices (MDR)

Directive 93/42/EEC concerning Medical Devices (MDD)

UL 2900 Software Cybersecurity

Health Insurance Portability and Accountability Act (HIPAA)

General Data Protection Regulation 2016/679 (GDPR)”

Sector(s) Served:

Digital Health; Life Sciences; Med Devices; Medtech; Wearable Technologies

Key Clients:

Philips, Baxter, Boston Scientific, Cochlear

Geographical sectors served:

Europe (Germany, Switzerland, Netherlands, France, UK), US

Contact Details:

Tel: +353 15632000

Email: Info@S3ConnectedHealth.com

Website: www.s3connectedhealth.com/connected-medical-devices-and-digital-health-solutions

Social Media:

Twitter: www.twitter.com/s3connectedH

LinkedIn: ie.linkedin.com/showcase/s3-connected-health-medtech-page