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.