Building new solutions is only one aspect of health innovation. Successful adoption by healthcare systems requires companies to navigate a complex path to compliance – meeting standards that touch every area of your business.
Our team draws on far-reaching expertise in every aspect of healthcare compliance to support you on your journey. We believe that compliance means more than meeting a checklist of requirements – the governance, leadership, and culture of organisations play an essential role in creating better healthcare outcomes.
Our team of domain specialists will handle every detail, helping you to focus on what you do best. We exist to reduce the burden of compliance on you and your team, guiding you through a smooth, seamless experience that ensures your business is equipped to address your customers’ needs.
We work with companies of all sizes, helping you find a route from where you are to where you need to be. With diverse expertise and experience, we can help you embrace “good governance” without distraction.
Information Governance & Data Protection
Clinical Safety
Medical Device
Regulations
Artificial intelligence
NHS Digital Technology Assessment Criteria
International
Standards
CQC Regulation
Cyber Security
We work with Startups and SME’s to establish solid foundations to drive better business and product outcomes.
We support global businesses to align their existing processes with UK and industry requirements, smoothing market entry.
Providers leverage our diverse expertise to deliver high quality care, enhanced by technology.
Larger organisations rely on
our support to complement their internal functions and bring sector-specific compliance knowledge.
Edmund Broadhead
CEO of Health Narrator
ZhiQian Huang
Chief Impact Officer & Co-Founder, Logan ToD & Co
8foldGovernance have been a great partner of patientMpower, assisting us primarily in information governance and clinical safety analysis and planning. Would highly recommend to any digital healthcare company looking to sell into the NHS.
Eamonn Costello
CEO & Co-Founder, patientMPower
8foldGovernance is our trusted regulatory partner. We have collaborated with the team since inception to launch of Ayla, your CST Assistant, working with them to develop our quality documentation, submit our documentation in line with UKCA and meet crucial information security and product safety standards necessary for the UK market.
Simon Nielsen
Chief Strategy and Innovation Officer, Brain+
Let us help you find a route from from where you are, to where you need to go. We’re here to help.
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