Every plan includes hands-on support from our clinical safety, data protection, quality and regulatory specialists, from scoping and onboarding to answering any question and reviewing your evidence before it reaches an assessor.
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Features
Your first sessions work out which frameworks genuinely apply to your product and organisation, because not every product needs DTAC and not everything is a medical device. Your workspace is then set up around that answer.
Get a shared Slack channel with our team, so any compliance question is answered by people who know the frameworks and know your product, not a ticket queue.
We review your documentation and evidence before it goes to a certification body, a notified body or an NHS buyer, so questions come from us rather than from them. For everything in between, Ask Assuric AI gives instant, cited answers about your workspace.
Our team includes NHS doctors and certified clinical safety officers, certified data protection officers, a former CQC inspector and medical device regulatory specialists.
We help you prepare for audits and inspections, from checking your evidence is complete to talking through what the assessor will look for, so you never face an audit on your own.
Add a Fractional CSO, Fractional DPO, CQC consultancy or penetration testing whenever you need it, delivered by the same team inside your workspace.
Benefits
Get a clear view of the frameworks and regulatory requirements that apply to your product and company, including what you don’t need to do.
Get expert advice based on your product, documents and records, rather than generic guidance that may not apply to you.
AI and automation handle the routine work, so our specialists’ time goes on expert advice, giving you consultancy-level support without consultancy fees.
Specialist-reviewed documentation and named experts show NHS buyers and partners you take compliance seriously.
Add a named CSO, DPO or other specialist whenever you need one, from a few hours a month to ongoing hands-on support.
“We couldn't speak highly enough of both the Assuric team and the platform itself, which is incredibly easy to use, and with the skill and hardworking nature of the Assuric team. They've been a key component in accelerating our progress and deployments!”
Maks Kozarzewski
COO, VitVio
“The Assuric platform is a game changer in the clinical risk management field. It has been carefully designed to make the job of a CSO significantly more streamlined. The team are excellent and responsive to any product suggestions I have requested, and it has been a pleasure to work with them.”
Paul Llewellyn
CCIO, Accenture
“Assuric has been fantastic in helping us quickly and safely navigate regulatory compliance in the UK. From completing Cybersecurity requirements to DSPT, DCB0129, and DTAC, the team was supportive, extremely knowledgeable, and the platform made everything quick and straightforward. A separate regulatory company we consulted at the beginning even remarked on how quickly we achieved compliance!”
Katie Baker
Director UK & Ireland, Tandem
Yes. Every plan includes onboarding, a shared Slack channel, expert reviews and answers to your compliance questions. Named roles such as a Fractional CSO or DPO are additional services.
Yes. That’s where onboarding starts: we work out which frameworks genuinely apply to your product and organisation and set up your workspace around them, including what you don’t need to do.
Through your shared Slack channel, in-app chat or email, and we’ll set up calls whenever something needs talking through.
Yes. As part of our Fractional CSO service, our clinical safety officers sign as your named Clinical Safety Officer (CSO) for DCB0129.
Yes. Our data protection specialists support DSPT, DPIAs, RoPAs and wider data protection work, and our Fractional DPO service can act as your named data protection officer.
We give you templates and AI drafting, tell you what’s needed and review what you produce. Drafting a full document set or taking on a larger piece of work is a separate service, and for some specialist areas we will introduce you to a partner consultancy.
Our clinical safety officers and a number of our team are clinically qualified, with 20+ years of clinical experience behind them. Our regulatory and data protection specialists work in digital health full time, with hands-on expertise advising and building healthtech products.
A consultancy is limited by how many people it has, and the documents it writes still need maintaining after it leaves. With Assuric, the platform tells you what’s needed and keeps your records current, and our specialists work through it with you inside the same system. If you do use a consultant, decide on your system first, so you’re not rewriting everything twice.
See how our specialists can help you get compliant fast and stay compliant easily.