A trusted partner for your HealthTech compliance journey

 

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Acorn Compliance specialises in helping you achieve and maintain compliance across all DTAC domains

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Clinical Safety

Clinical Safety Risk Management System

DCB0129 compliance

DCB0160 compliance

Hazard logs and Safety cases

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Data Protection

NHS DSPT Toolkit

GDPR product alignment

Data Privacy Impact assessment

Cyber Essentials

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Interoperability

Strategy

API Standards

EPR / EHR / EMR connectivity

GP Practice connectivity

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Usability & Accessibility

WCAG 2.1 AA compliance

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Usability study templates

Benefits study templates

We help you succeed in the highly regulated healthcare industry

With over 20 years healthcare consulting experience supporting suppliers, NHS Trusts, care providers, investors and NHSX, we are a trusted partner who can help your HealthTech innovation succeed.

We are experts in advising and delivering on all aspects of UK and international HealthTech compliance (including NHS DTAC standards), as well as related ISO standards and Medical Device Regulations, and we can work with you to steer your product to full compliance and ready it for market.​​

Accessible, compliant HealthTech is critical to grow your userbase, revenues and reputation. Moreover it can help save lives.​

Given our extensive startup experience and understanding of startup culture, pressures and constraints, we take a pragmatic but rigorous approach to compliance that is aligned to your product and vision.

"HealthTech Compliance 101" 

 

Watch this recorded webinar to find out more about HealthTech compliance and your next steps to achieve it. 

What you will learn:

  • What HealthTech compliance is and why it's important for you
  • What are the practical steps you need to take to make sure your product is compliant
  • Answers to the most common questions

Available to watch for free by filling in this form.

Watch Our Recorded Webinar

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Outsource Compliance 

Outsource your compliance requirements with our Compliance as a Service offer.

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Our Services

BASIC

Compliance Coaching 

£390 per month +VAT

For startups with an unlaunched HealthTech product​ who want to accelerate revenue generation and growth.

 

 

PLUS

Compliance Consulting​

£1550 per month +VAT

For startups ready to launch a product who require a lot of help with DTAC compliance and need access to a procurement framework.

 

 

PRO

Compliance Officer as a Service

£2700 per month +VAT

For companies who wish to completely outsource their DTAC compliance with guaranteed certification, have access to a procurement framework and benefit from a HealthTech strategist to aid growth and product development.

Compare Plans

Why Outsource DTAC compliance?

  • Ensure your product is procurable to the NHS

  • Practical and cost-effective solution for organisations lacking the requisite resources or expertise to achieve and maintain DTAC compliance

  • Lower cost than hiring a healthcare compliance officer

  • Our compliance officers have many years of experience across all DTAC domains and have already helped HealthTech companies successfully achieve and maintain DTAC

  • Transparent costs and service description

  • No conflict of interest as a third party assesses and warranties your compliance status

Our Monthly DTAC Plans

BASIC

£390/m

Compliance Coaching

  • Dedicated Compliance Coach to help you towards DTAC
  • 2 x 1 hour Q&A sessions per month to aid your DTAC journey
  • Pragmatic, step by step guidance for DTAC
  • Provision of usable templates and relevant policies for DTAC
  • Provision of new or updated templates should any aspect of DTAC compliance change throughout your contract
  • Pragmatic, step by step guidance for DTAC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SELECT PLAN

PLUS

£1550/m

Compliance Consulting

  •  Discovery session to advise on your DTAC status
  • An initial gap analysis and remedial action plan
  • Build a compliance roadmap for your HealthTech product
  • 2 x 1 hour coaching / training sessions per month to aid your DTAC journey and delivery of strategic advisory for your HealthTech products and services
  • 2 working day reply to your DTAC related questions
  • Templates and relevant policies for appropriate DTAC areas and regular updates in line with any changes to DTAC related legislation
  • 2 working day reply to DTAC related compliance queries
  • Annual Cyber Essentials completion
  • Annual NHS DSPT audit completion plus updating of your NHS DSPT response should there be question changes
  • Creation and maintenance of Clinical Safety Risk Management System
  • Creation and maintenance of DCB0129 Clinical Safety Hazard Log and Safety Case Report creation
  • Access to a single suitable procurement framework, e.g. Spark DPS or G-Cloud 13
  • Covers max 3 related products, e.g. iOS, Android and WebApp

 

 

 

 

SELECT PLAN

PRO

£2700/m

Compliance Officer as a Service

  • Discovery session to advise on your DTAC status
  • An initial gap analysis and remedial action plan
  • Dedicated Compliance Officer covering all DTAC domains who will maintain your DTAC evidence file in line with your product development
  • 2 x 1 hour strategic advice sessions per month to use as you wish to aid your product development, assist with procurements, or help embed a compliance culture within your organisation
  • Creation of a compliance roadmap and calendar
  • Templates and relevant policies for appropriate DTAC areas and regular updates in line with any changes to DTAC related legislation
  • Creation of your entire DTAC evidence file and monthly maintenance
  • Initial WCAG 2.1 AA accessibility audit
  • Monthly hazard log review
  • Product feature impact against all DTAC areas (per release)
  • Annual Cyber Essentials
  • Annual NHS DSPT audit completion plus updating of your NHS DSPT response should there be question changes
  • 1 working day reply to DTAC related compliance queries
  • Interoperability - strategic guidance in relation to DTAC
  • Full DTAC warranty to guarantee PASS with NHS authorities
  • Access to a single suitable procurement framework, e.g. Spark DPS or G-Cloud 13
  • Covers max 3 related products, e.g. iOS, Android and WebApp
SELECT PLAN

All prices above are quoted exclusive of 20% VAT (automatically added at checkout).

What's NOT included: 

Please note that the following services are not included in any of the price plans. We may however be able to advise on partners to supply the these services, on request.

  • External Penetration Testing
  • Acting as your Data Protection Officer (DPO)
  • Acting as your  Clinical Safety Officer (CSO)

Other compliance services: 

In addition to our monthly plans, we offer other services as follows:

  • Fast track DTAC - become fully compliant within 6 weeks
  • ISO27001 and ISO9001 certification
  • Medical Device Regulation support

Note: For complex Medical Device Regulation work we work with a partner organisation.

Book a discovery call to find out more

What Clients Are Saying

HealthTech startups recommend our services 

Logo Tympa Health
"It was great to work with Acorn Compliance. They were able to deliver our scope of work to time and fitted into the team seamlessly. I could not recommend them any more and we will be certainly using them for more projects."

Krishan Ramdoo
CEO - Tympa Health Technologies Ltd

 

Logo Doc Coms
"With a professional, reliable and extremely efficient approach, Acorn Compliance have assisted us in navigating the complex and heavily regulated healthcare market, to ensure DocComs attained all the required regulatory compliance and was accessible to purchase for the NHS."

Roseanna Jaggard
CEO, DocComs

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Value Associates Limited, Trading as Acorn Compliance is a company registered in England & Wales (Registration Number: 5770395)

Registered Office: KD Tower, Suite 2 Cotterells, Hemel Hempstead HP1 1FW

Visit Value Associates Limited website.