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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. Health compliance consultancy for Digital Clinical Safety.

Features

  • Support for DCB 0129 compliance and DCB 0160 compliance
  • Outsourced Clinical Safety Officer services
  • DCB0129 training courses and DCB0160 training courses
  • Medical Device consultancy for Software as a Medical Device (SaMD)
  • DTAC completion support
  • 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 formulation, Safety Case training and Safety Case support
  • Dedicated Clinical Safety Officer (CSO) expertise
  • Inject independence into your digital clinical safety strategy
  • Develop a local Clinical Safety Officer capability
  • Clinical Safety Training for Continuing Professional Development
  • Does the Medical Device Regulation apply to your product?
  • Technical File development for your software Medical Device
  • Objectively review your assurance debt to prioritise DCB0160 risk assessments

Pricing

£895.00 to £1,050.00 a unit a day

Service documents

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 contactus@safehand.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 14

Service ID

8 8 9 9 2 0 1 0 9 6 6 7 4 5 2

Contact

SAFEHAND CONSULTING LIMITED Dr. Adrian Stavert-Dobson
Telephone: 0114 4000455
Email: contactus@safehand.co.uk

Planning

Planning service
No

Training

Training service provided
Yes
How the training service works
Safehand provides CPD-accredited onsite clinical safety training for your Clinical Safety Officer and entire project team. We teach the detailed techniques of proactive clinical risk management and DCB 0129 / DCB 0160 compliance.
Our courses are delivered by an experienced Clinical Safety Officer over two consecutive days at a venue of your choosing. You are free to invite as many attendees as you wish providing they are employees of your organisation. The course covers the following topics: Introduction to DCB 0129/0160 and Digital Clinical Safety, Preparing for Clinical Risk Management, The hazard log and clinical risk evaluation, Populating the hazard log, The Safety Case, Developing controls strategies, Clinical risk management in live service, Documenting concerns and incidents.
Most Trusts have some specific areas of interest and we will discuss these with you to ensure we focus on the areas most relevant to your challenges.
The course can be used as an alternative or supplementary to NHS Digital’s Accredited Clinician Course in order to meet the Competency requirements of DCB 0160. Attendees of the course can claim 11 CPD points.
Training is tied to specific services
No

Setup and migration

Setup or migration service available
No

Quality assurance and performance testing

Quality assurance and performance testing service
No

Security testing

Security services
No

Ongoing support

Ongoing support service
Yes
Types of service supported
Hosting or software provided by a third-party organisation
How the support service works
Safehand provides Clinical Safety Officer services in order to complete the DCB 0129 and DCB 0160 Clinical Risk Management work on behalf of healthcare organisations and digital health suppliers. This Digital Clinical Safety assessment needs to be conducted for all cloud solutions which are capable of impacting the care of individual patients. Our team of expert Clinical Safety Officers construct the necessary reports meaning that organisations no longer need to spend time and money diverting existing clinical staff from their otherwise busy roles.
Safehand can also work with healthcare organisations to develop their own CSO capabilities through the provision of training and support. We evaluate an organisation’s assurance debt, existing resources, skills and capabilities particularly focussing on accountability, culture and scalability. We teach organisations to appraise their backlog of un-assessed systems and to build a scalable team to tackle legacy and existing DCB 0160 analyses.

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
Email or online ticketing
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
Staff screening not performed
Government security clearance
Up to Baseline Personnel Security Standard (BPSS)

Standards and certifications

ISO/IEC 27001 certification
No
ISO 28000:2007 certification
No
CSA STAR certification
No
PCI certification
No
Cyber essentials
Yes
Cyber essentials plus
Yes
Other security certifications
No

Social Value

Social Value

Social Value

  • Fighting climate change
  • Equal opportunity

Fighting climate change

Safehand works continually to operate with a low carbon footprint. A number of important initiatives are set out below:
Safehand has eliminated the need for physical office space therefore removing the need to heat and light large office facilities.
All Clinical Safety Officers work from home eliminating the need to commute to an office.
Safehand provides staff with equipment to facilitate ‘contact’ heating such as heated blankets and chairs rather than requiring them to heat their houses or rooms by traditional methods.
Where we travel to customer sites, our travel policy prioritises the use of public transport over the use of personal vehicles.
Laptops and monitors are selected based on their energy efficiency profile.
Laptops are configured by default to enter power saving mode when not in use.
Safehand has eliminated the need for its own servers and file stores. Instead the company makes use of Microsoft cloud services. This means that the only dedicated physical infrastructure consists of highly efficient client workstations.
Safehand uses a pension provider who is committed to lowering their carbon footprint and who selectively invests in non-fossil fuel shares.

Equal opportunity

Safehand has implemented a strict equal opportunity and diversity policy. Safehand employs more women than men. All Team Leaders and Chief Operating Officer are women. 50% of the company’s directors are female.

Pricing

Price
£895.00 to £1,050.00 a unit a day
Discount for educational organisations
No

Service documents

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 contactus@safehand.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.