Simply, we help you achieve compliance so that customers and their buyers have confidence in your product.
There are different routes to achieving compliance, depending on the nature of your product or service, and how far along the compliance journey you already are. We will get to know you, your product and your business goals, so that we can create a tailored solution. This might be a simple assurance of your current documents, or full support and ongoing consultancy.
HOW WE DO IT
We take you through three simple steps to achieve compliance:
- Understand – we take a deep dive into your business to learn about who you are, your products and your goals. We assess any compliance work you may have already done and create a tailored plan to help you achieve compliance with the greatest efficiency.
- Deliver – we put your tailored plan into action. Our rich archive of materials and tools means we can rapidly create the documents you need to comply with the multitude of digital health standards.
- Sustain – once compliance has been achieved, we can help you maintain your status for existing, new and updated products, and fulfill the ongoing assessments required.
Information Governance as a Service (IGaaS)
If you hold personal information about your customers then, by law, you must protect it!
You may not have to hand an expert in data protection. Our IGaaS provides a DPO when, where and for as long as you need them.
Data Protection
Do you process NHS patient or customer data? If so, you’ll need evidence that you have systems and processes in place to protect the data, and remove it if requested. We can provide a Data Protection Officer, who will help you to identify and minimise risks and complete compulsory assessments, that are required on an ongoing basis.
Our IGaaS will help you comply with your data protection requirements.
Clinical Safety as a Service
(CSaaS)
The law requires you to ensure that your software is clinically safe for use in health care settings. This means you must minimise the potential for harm to patients. Our CSaaS provides Clinical Risk Management services and a Clinical Safety Officer when, where and for as long as you need them.
ISO 27001 & 9001
Our Information Governance as a Service option will quickly set up an ISMS & QMS that includes the technical, physical and legal procedures and policies required for information risk management. This framework is ready to be integrated into your business.
Digital Technology Assessment Criteria as a Service (DTACaaS)
If your product stores, collects or uses NHS data, then you need to complete a DTAC.
Like any journey, if you’ve not travelled it before, its always much easier and quicker with a guide. We will partner you along this process, we know how to get you there in the most efficient route, we speak the language of the NHS so that you don’t have to!