DCB0129
COMPLIANCE.

We collaborate with Health IT Manufacturers, whether they are large corporations or small enterprises, to ensure compliance with mandated standards. 

Our services encompass various aspects, including completing comprehensive product documentation, conducting hazard assessments, and providing feedback on digital readiness and overall product safety.

We offer recommendations across the board, from User Interface (UI) design to the implementation of additional safety controls. Throughout the entire product lifecycle, from design to deployment, our team guides and supports yours, ensuring that key activities are integrated seamlessly.

Furthermore, we aim to provide training to all team members, ensuring a basic understanding of the importance of these key activities. We also work closely with manufacturers to review existing policies and procedures or develop new frameworks to facilitate quality assurance. This includes implementing gateways within development cycles, from initial design to product release, and managing incidents and ongoing product maintenance.

Having clinicians or experienced professionals involved in the design process is imperative for any health and care product. Design features play a crucial role in ensuring the safety and assurance of the product. In all related areas, we offer expertise and support.

DCB0160
COMPLIANCE.

In the realm of healthcare technology, ensuring patient safety and the effective deployment of Health IT Systems is paramount. 

The DCB0160 Clinical Risk Management standard serves as a guiding framework for healthcare organisations to mitigate risks associated with the deployment and use of Health IT systems, software and apps.

Compliance with DCB0160 is more than a regulatory requirement, it’s a driver to deliver healthcare solutions that prioritise patient well-being, assist workforces, while ensuring no increased harm comes to the patient. It also signifies a commitment to transparency, accountability, and the continuous improvement of healthcare technology.

At DigiSafe Consulting, we understand the complexities involved in achieving DCB0160 compliance, especially for deploying organisations where resource is already stretched.  

Our team of clinical experts are dedicated to guiding you through the compliance journey, ensuring that your Health IT systems meet and exceed DCB0129 requirements and in-turn fit for deployment. 

WHAT

WE DO.

For both of the above, we can create your:

  • Clinical Risk Management System
  • Clinical Risk Management Plan 
  • Hazard Log
  • Clinical Safety Case Report  

Complete a Comprehensive Risk Assessment

We conduct a thorough risk assessment of your health IT systems, software, app or deployment. Identifying potential clinical risks and vulnerabilities. We provide clear recommendations for mitigation.

Documentation
Support 

We assist in the preparation of all necessary documentation to meet DCB0160/0129 requirements, ensuring that your deployment processes are well-documented and compliant.

Clinical Safety
Enhancements 

We collaborate closely with your team to implement clinical safety measures, from user interface enhancements to hazard assessments, safeguarding patients and healthcare professionals.

Training and Knowledge Sharing

We provide training to your team members, ensuring a deep understanding of the importance of DCB0160/0129 compliance and empowering them to contribute effectively.

Ongoing Compliance Maintenance

Our commitment extends beyond initial compliance. We offer continuous support to ensure that your health IT systems or services remain compliant as clinical safety standards evolve.

Find Out More

Ready to embark on your DCB0129/0160 compliance journey or seeking guidance on maintaining compliance? 

Read more about the 
Requirements here.

DTAC
ASSURANCE.

In the ever-evolving landscape of healthcare technology, compliance with regulatory standards has become paramount. 

Ensuring the safety and effectiveness of digital health solutions is not just a regulatory requirement; it’s a commitment to delivering high-quality care and maintaining the trust of patients and healthcare professionals.

At DigiSafe Consulting, we understand that navigating the complex realm of compliance, particularly when it comes to the Digital Technology Assessment Criteria (DTAC), can be a daunting task for software manufacturers. However, it’s a journey that cannot be overlooked or underestimated.

DTAC compliance serves as a vital benchmark for healthcare software manufacturers. It’s a set of criteria that evaluates the safety, quality, and functionality of digital health solutions.

 Achieving DTAC compliance not only ensures adherence to stringent regulatory standards but also signals a commitment to patient safety and the delivery of efficient healthcare services.

Non-compliance can have severe consequences, including delays in product launches, potential legal issues, and damage to reputation. More importantly, it can compromise patient safety and hinder the advancement of healthcare technology.

By partnering with DigiSafe Consulting, you not only ensure compliance with DTAC but also gain a competitive edge in the dynamic healthcare technology market. Our expertise, dedication, and commitment to patient safety will help you navigate the compliance journey with confidence, ultimately delivering safer and more reliable digital health solutions.

Comprehensive
Assessment

We conduct a thorough evaluation of your software against DTAC criteria, identifying areas of improvement and providing clear recommendations for compliance.

Documentation
Support 

We assist in preparing all necessary documentation, ensuring that your submission meets the stringent requirements of DTAC.

Quality Assurance

We work closely with your team to implement necessary safety controls, from User Interface design enhancements to hazard assessments, helping you create a safer and more effective product.

Training and
Mentorship

We provide training to your team members to ensure everyone understands the importance of DTAC compliance and can actively contribute to the process.

Ongoing Support

Our commitment extends beyond achieving compliance. We offer ongoing support, ensuring that your software remains compliant as regulations evolve.

Find Out More

Ready to embark on your DTAC compliance journey or seeking guidance on maintaining compliance? 

Read more about the 
Requirements here.

DSP
TOOLKIT.

DSP Toolkit compliance is essential. It’s a comprehensive set of requirements and best practices aimed at safeguarding patient data, ensuring that sensitive information remains confidential, and protecting against data breaches and cyber threats. 

Compliance not only mitigates legal risks but also enhances the reputation of your organisation as a trusted custodian of patient data.

Failure to comply with DSP Toolkit standards can lead to data breaches, legal penalties, reputational damage, and loss of patient trust. The consequences of non-compliance extend far beyond regulatory fines; they affect patient well-being and the credibility of your digital health solutions. This is another component of DTAC compliance. 

Therefore, at DigiSafe Consulting, we recognize that achieving and maintaining DSP Toolkit compliance can be a complex and demanding task for software manufacturers. 

That’s why our team of experts is here to assist you every step of the way, ensuring that your digital health solutions meet and exceed DSP Toolkit requirements.

Achieving Data Security and Protection Excellence with DigiSafe.

Thorough
Assessment

We conduct a meticulous evaluation of your software to identify areas where DSP Toolkit compliance may be lacking, providing actionable recommendations for improvement.

Documentation
Support

We assist in the preparation of all necessary documentation to meet DSP Toolkit requirements, helping you navigate the intricate paperwork with ease.

 

Data Security Enhancements

We work collaboratively with your team to implement robust data security measures, from encryption and access controls to threat assessments, safeguarding patient data against potential threats.

 

Training and
Knowledge Sharing

We provide training to your team members, ensuring a deep understanding of the significance of DSP Toolkit compliance and empowering them to contribute effectively.

Ongoing Maintenance

Our commitment extends beyond achieving initial compliance. We offer continuous support to ensure that your software remains compliant as data security standards evolve.

TRAINING,
MENTORSHIP,
CONSULTANCY.

Our associates have years of experience In varied health, care and software environments, with in-depth knowledge ready to share, guide and lead you through your journey.

We are here to support you with infinite amount of best practices and requirement advice which ensures compliance and assurance. We also offer CPD accredited FCI approved Clinical Safety Officer training.

FIND OUT MORE.

Ready to embark on your DCB0129/0160 or DTAC compliance journey or seeking guidance on maintaining compliance? 

Read more about the Requirements here.