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Software as a Medical Device

Take your medical device software to market, faster

Overview

Software as a Medical Device (SaMD) requirements

If your software diagnoses, monitors, treats or prevents a medical condition, it is likely regulated as a medical device. Assuric helps healthtech and AI companies determine whether they are in scope and manage everything from ISO 13485 and ISO 14971 to IEC 62304, clinical evaluation and MHRA registration, all in one platform.

Classification

From Class I to Class III

Risk rises with class, and so does the work to reach market. Your intended purpose decides where you sit.

Low risk

Class I

Lowest risk. Self-certification and MHRA registration, the fastest route to market.

Most SaMD starts here
Moderate risk

Class IIa

Moderate risk. An approved body assesses your device from here upwards.

Higher risk

Class IIb

Higher risk. Deeper approved body scrutiny of your technical documentation.

Highest risk

Class III

Highest risk. The most demanding conformity assessment before market.

Not sure if you are a medical device?

Tell us what your product does and we will help you work out whether you are in scope, and what class you are likely to be.

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We are trusted by

  • Infix
  • Coreline
  • Suvera
  • Nursebuddy
  • Accurx
  • Cleo
  • Sanome
  • Heidi
  • Eolas
  • Tandem
  • Circle Health Group
  • Heim
  • Hippo Labs
  • Delfa
  • Guardant
  • Medcurrent
  • Surgery AI
  • Welby Innovate
  • Hesta Health
  • Kanjo
  • Rosenfield
  • VitVio
  • Megi Your Health Assistant
  • Chequp
  • Rhades
  • Joy
  • ONION AI
  • Think Divergent
  • Theta
  • Healthnix
  • Infix
  • Coreline
  • Suvera
  • Nursebuddy
  • Accurx
  • Cleo
  • Sanome
  • Heidi
  • Eolas
  • Tandem
  • Circle Health Group
  • Heim
  • Hippo Labs
  • Delfa
  • Guardant
  • Medcurrent
  • Surgery AI
  • Welby Innovate
  • Hesta Health
  • Kanjo
  • Rosenfield
  • VitVio
  • Megi Your Health Assistant
  • Chequp
  • Rhades
  • Joy
  • ONION AI
  • Think Divergent
  • Theta
  • Healthnix
Product

How Assuric can help

We can support you across the whole route to market:

Work out your classification

Get clear on whether you are a medical device, and whether you are Class I, IIa, IIb or III. Your intended purpose drives the whole thing, and the exact wording matters, so getting it right early can save you a great deal of time and cost.

Class I self-certification

The fastest route to market for lower-risk software. We help you prepare your technical file, clinical evaluation and declaration of conformity, and register with the MHRA.

ISO 13485 quality management

Build the quality management system notified bodies and buyers expect, with controlled documents and e-signatures. See our ISO 13485 page for the detail.

Risk and software lifecycle

Manage your ISO 14971 device risk management and your IEC 62304 software development traceability in one place, linked to the rest of your quality system.

AI as a Medical Device (AIaMD)

If your product uses AI, we fold AI-specific policies into your quality system so you meet expectations without a separate regime. Practical, not painful.

Clinical safety (DCB0129)

Meet the clinical risk management the NHS expects from manufacturers, and reuse that work across your medical device documentation. See our DCB0129 page.

Expert regulatory support

Work with our team for ad-hoc advice or hands-on help, including acting as your Clinical Safety Officer where you need one. You get people who have done this before, not just software.

testimonials

What our customers say

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

Kelly Klifa
Heim

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
Tandem

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
VitVio

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
Healthnix

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
DPM

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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