DTAC Compliance Services 

Fast Track Packages
Monthly Subscriptions
Bespoke Offers

Fast Track Packages

Achieve DTAC in 6 weeks or less. What’s included:

  • A gap analysis against the DTAC standard covering all DTAC domains
  • Creation of all your outstanding DTAC evidence
  • Compliance culture coaching to ensure continued alignment with DTAC
  • Any further feedback sessions to support your DTAC efforts
  • A warranty for your completed DTAC file related to a specific product release(s)

Call us to find out more and get a price.

Book Your Free Discovery Call

Monthly Subscriptions

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BASIC PLAN

Do it yourself

Compliance Coaching

 

£390 + VAT

Minimum duration 12 months.

For startups with an unlaunched healthtech product​ who want to accelerate revenue generation.

What's Included:

  • Dedicated DTAC Compliance Coach
  • 2 x 1 hour coaching sessions per month to aid your DTAC journey
  • Templates and relevant policies for appropriate DTAC areas and regular updates in line with DTAC legislation changes
  • Pragmatic, step by step guidance for DTAC 
  • Advice and guidance on creating a compliance culture so that you can maintain DTAC
  • Limited to 1 product

What's NOT included but available as an additional service:

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

Done in partnership

Compliance Consulting

 

£1550 + VAT

Minimum duration 12 months.

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

What's Included:

Everything in the BASIC plan, plus:

  • Discovery session to advise on your healthtech compliance status, inclusive of review against all DTAC domains
  • Gap analysis, remedial action plan and compliance roadmap 
  • Full creation of your DTAC evidence file for all DTAC domains including 
    • Clinical Safety Risk Management System
    • DCB0129 Clinical Safety Hazard Log
    • Safety Case Report
  •  DTAC evidence file fully covered by our warranty
  • Annual Cyber Essentials completion
  • Annual NHS DSPT audit completion plus updating of your NHS DSPT audit response should the NHS DSPT questions change throughout your contract
  • Access to a single suitable procurement framework, e.g. Spark DPS or NHS Supply Chain
  • Covers max 3 related products, e.g. iOS, Android and WebApp
  • 2 working day reply to your questions

What's NOT included but available as an additional service:

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

Fully outsourced

Compliance Officer as a Service

 

£2700 + VAT

Minimum duration 12 months.

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.

What's Included:

Everything in the PLUS plan, plus:

  •  Dedicated Compliance Officer to support you with product development, procurement questions, NHS engagement, and to embed a compliance culture in your organisation

  • 2 x 1 hour strategic advice sessions per month with your dedicated compliance officer per month to cover topics such as
    • Product development
    • Procurement
    • Interoperability
  • Full WCAG 2.1 AA accessibility audit
  • Monthly product feature impact against all DTAC areas (per release) and update of your DTAC evidence file. Review includes:
    • Clinical safety
    • Data protection
    • External custom code security check
  • 1 working day reply to DTAC compliance queries
  • Ongoing DTAC warranty to guarantee PASS with NHS authorities

What's NOT included but available as an additional service:

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

DTAC Evidence File Warranty 

For the PLUS and PRO plans you are covered by a full warranty: 

  • Should your DTAC evidence file be deemed not acceptable by any reviewing body, we will remedy any required aspects free of charge.
  • If needed, we will work with the procuring authority to help them fully understand your DTAC evidence file and to ensure its assessment is rapidly completed.
  • Any such work will be free of charge and completed within 5 working days. 

Please note this warranty does not include a provision for any ongoing work you may need to undertake on our advice, such as updating your digital product(s), to ensure they remain clinically safe, secure, interoperable or accessible in line with DTAC.

Not finding what you need?

We can assist with specific compliance needs: 

  • An urgent need to become fully DTAC compliant,  or complete a specific audit such as DSPT or Cyber Essentials Plus
  • A need for bespoke interoperability input and guidance
  • Product Ownership services to guide you product to Healthcare market success
  • Multiple and substantially different products that require compliance certification
  • Access to international compliance certification (e.g. HIPAA for US market)
  • External Penetration Testing
  • Acting as your Data Protection Officer (DPO) or  Clinical Safety Officer (CSO)

For a confidential discussion on your specific healthtech compliance needs, book your free discovery call.

Book Your Free Discovery Call

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