Digital Health & Cybersecurity
We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU.
Our services include the following devices:
• Medical devices (and accessories)
• In-vitro diagnostic devices (and accessories)
• Wellness / lifestyle devices
• Software as a medical device (SaMD) including mobile, web and cloud-based applications
We are the foremost provider of Software Quality Assurance to the emerging digital healthcare industry as a one stop solution to companies who seek to have medical devices that are solely/predominantly software through registration for CE Mark or FDA approval.
We can help you with a range of services including:
• DCB0129 / DCB0160: Clinical Risk Management in Health IT Systems (NHS Digital) Compliance
• Access to the NHS Marketplace
• Cyber Essentials / Cyber Essentials Plus Certification
• IEC 62304: Software life cycle processes Compliance
• ISO 27001: Information security management Compliance
• GDPR Compliance
As your ‘Independent Quality Unit’ we will represent your business/products in all dealings with any regulatory agency. We offer total solutions for CE Mark/FDA registration requirements.