SAFEHAND CONSULTING LIMITED

Digital health regulatory and compliance consultancy for DCB0129 and DCB0160

Regulatory consultancy for digital health products including DCB 0129, DCB 0160 and Medical Device Regulation. Outsourcing of the Clinical Safety Officer role, development of local DCB0160 capabilities and provision of DCB0129 and DCB0160 training courses. Clinical Risk Management consultancy for Digital Clinical Safety, Digital Health Technologies and AI-based systems.

Features

• Support for DCB 0129 compliance and DCB 0160 compliance
• Outsourced Clinical Safety Officer services and Digital Health Compliance
• DCB0129 training courses and DCB0160 training courses
• Medical Device consultancy for Software as a Medical Device (SaMD)
• Legacy Assurance Debt Management for Digital Health Technologies
• Clinical Safety Case Report drafting and Hazard Log drafting
• Clinical Safety Consultancy and Clinical Risk Management Consultancy
• Digital Clinical Safety Consultancy and DTAC Consultancy
• Clinical Safety Officer training (CSO training)
• Develop local Clinical Risk Management function and Clinical Safety Process

Benefits

• DCB0129 risk assessments and DCB0160 risk assessments
• Hazard Log formulation, Hazard Log training and Hazard Log support
• Safety Case development, Safety Case training and Safety Case support
• Dedicated Clinical Safety Officer (CSO) expertise on demand
• Independent assurance to strengthen your digital clinical safety strategy
• Develop and embed an internal Clinical Safety Officer capability
• Clinical Safety training aligned to Continuing Professional Development (CPD)
• Determine whether the Medical Device Regulation applies to your product
• Establish a sustainable Clinical Risk Management framework within your organisation
• Independent review of assurance debt to prioritise DCB0160 risk assessments

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at adrian@safehand.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 15

Service ID

777952254837388

Contact

Adrian Stavert-Dobson
07980 272491
adrian@safehand.co.uk

About your service

• Service categories:

  Cloud Support Services

  Quality Assurance and Performance Testing

  • Assurance/testing design
  • Other

Service scope

• Service constraints: Safehand’s services are available 9am-5:00pm Monday to Friday. Safehand cannot guarantee that a safety assessment will conclude that the product is associated with an acceptable degree of Clinical Risk. To do so would undermine the assessment process. We do however, at the earliest opportunity, inform our customers of any potential concerns. Safehand is only able to build reports based on the information disclosed to us by our customers. If the data for the analysis is not provided, it may not be possible to construct a complete report.

User support

• Email or online ticketing support: Yes
• Support response times: Safehand aims to answer all emails and return all calls within 48 hours, excluding weekends and Bank Holidays.
• User can manage status and priority of support tickets: No
• Phone support: Yes
• Phone support availability: 9 to 5 (UK time), Monday to Friday
• Web chat support: No
• Support levels: Our Clinical Safety Officers provide remote support directly to our customers via telephone, email and conference call. We support most of our customers on an on-going basis within the order of one day per month charged at our agreed daily rate. However, this can vary between customers and the precise engagement model is decided in the course of the engagement.

Resellers

• Supplier type: Not a reseller

Staff security

• Staff security clearance: Other security clearance
• Government security clearance: Baseline Personnel Security Standard (BPSS)

Pricing

• Discount for educational organisations: No

Product and delivery roles

Business analyst

Role level	UK Rate	Offshore Rate
Business analyst	£995.00
Senior business analyst	£995.00
Lead business analyst	£1,100.00
Head of business analysis	£2,000.00

Non-mandatory Standards and certifications

• ISO/IEC 27001 certification: No
• ISO 28000:2022 certification: No
• ISO 9001 certification: No
• Quality management systems (QMS): Yes
• CSA STAR certification: No
• PCI certification: No
• Cyber essentials: Yes
• Please provide your Cyber Essentials Certificate Number: 199470e4-1d9c-4d97-8d08-dfc7aecfcdb8
• Cyber essentials plus: No
• Cyber Essentials Alternative: You do not have a current and valid Cyber Essentials Plus certificate, or will not have in place within 12 months of the date of award but have an IASME certified equivalent.
• Other security certifications: No

Social value

• Section B - Commitment for Future: Delivery:

  • Mission: Kick start economic growth. To secure the highest sustained growth in the G7 - with good jobs and productivity growth in every part of the country making everyone, not just a few, better off.

    Policy Outcome 1: Fair work: That offers fair wages and good working conditions. Help people get a job, stay in work, and progress in their careers, with good employment opportunities across the country. Notes: Where there is a large proportion of labour costs in the contract, commercial teams should consider MAC in Outcome 1 as a priority

    • Employment contracts that reflect actual hours worked; steps taken to ensure employees understand their contracts and have the ability to review and adjust them if actual hours regularly exceed contracted hours
    • Payment of more than the National Minimum Wage or National Living Wage (as appropriate) to the contract workforce
    • Monitoring and reporting of gender and ethnicity pay gaps and plans to address them where necessary
    • Support for the contract workforce by providing career advice, and providing opportunities for staff working on the contract with in-work progression career development into known skills shortages or high growth areas
    • Volunteering opportunities for staff

Service documents

• Pricing document

  PDF

• Service definition document

  PDF

• Terms and conditions

  PDF

Request an accessible format

If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at adrian@safehand.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.