Assuric

Solutions

Clinical Safety

Manage clinical risks and ensure patient safety when implementing new technologies

Overview

Meet all the
Digital Clinical Safety Requirements

We work with digital health and healthtech companies of all sizes, as well as healthcare organisations to ensure digital products are safe and clinical risks are managed well.

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How Assuric can help

We can assist you with all aspects of clinical safety

Automated compliance with DCB0129 and ISO14971

Easily fill any gaps, automate tasks, track compliance and receive proactive alerts - ensuring requirements are met in record time.

Specialised Risk Management and Hazard Log

Best-in-class hazard log designed by Clinical Safety Officers and specialised for DCB0129 to produce documents like the Clinical Safety Case Report. Manage hazards, causes, controls and evidence across multiple projects. Referenced to the implementation guidance throughout.

Manage multiple projects

Work across multiple complex projects. Avoid duplication of work by linking hazards, causes and controls across projects. Review and approval system and collaborative working throughout the platform.

Automated report generation

Create automated reports to share with your company - ranging from CSO updates for your clinical safety team to board level reports showing high level risks to your executive team.

Clinical safety incident management

Manage clinical incidents in line with the implementation guidance. Assign owners and link across hazards and controls.

Centralised dashboard for key hazard and incident oversight

Overview of all live risks and unresolved incidents for management. Understand areas of high risk across multiple projects to ensure risks are minimised. Review incidents to spot patterns and areas of weakness in new technologies to minimise risk.

Training and Staff Compliance

All the necessary staff training you’ll need (both basic and specialist), combined with automated tracking and reminders to ensure compliance.

Expert fractional CSO consultancy services

Our team of expert consultant Clinical Safety Officers can help you with all aspects of clinical risk management, including producing all key documentation, being a named CSO for your company and managing any digital clinical incidents that occur.

$Expert fractional CSO consultancy services$

Comprehensive support

Expert support from our team of Clinical Safety Officers including ad-hoc advice as required to help you through all aspects of clinical risk management.

testimonials

What Our Customers Say

Compliance is complex, but our AI tools simplify it. Discover features to stay ahead of regulations.

Kelly Klifa

CEO at Heim

Assuric has been transformative for Heim as we looked to achieve DCB0129 and DTAC compliance. The platform is easy to use, and the AI tools and automated reminders make previously dreaded compliance tasks a breeze. Paul and Matt supported us every step of the way.

Katie Baker

Director UK & Ireland at Tandem

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!

Maks Kozarzewski

COO at VitVio

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!

Maja Mazur

CEO at Healthnix

Assuric has been such a blessing in getting our DTAC and GDPR compliance done - completing all the documentation and deciding what needs to be done whilst running the business is very hard, but the team really helped us through that. The platform is easy to use, helps keep track of things and it even allows us to coordinate all the team training easily. Highly recommend them!

Dean Mawson

Clinical Director at DPM

Assuric streamlines the process of achieving and maintaining compliance with DCB0129 standards for digital health technologies. The user-friendly interface simplifies collaboration across multidisciplinary teams, while the built-in templates and workflows save significant time and effort during compliance projects. Assuric’s ability to centralise documentation and provide real-time visibility into project progress is particularly beneficial for Clinical Safety Officers and digital project teams, enhancing both efficiency and assurance.

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