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In this short film Managing Director Nick Dodds discusses ISO 9001 and their working towards ISO 27001 Information Security Management and ISO 13485 Medical Device Directive Certification.
“Where Episode Consultants really add value is that they help us keep up to date with the evolving standards. Maintaining that relationship allows us to understand how we need to continually adapt and improve to stay in line with the standard. Secondly, we think there's a lot of value in having an external view of the performance of our business and the quality. Using Episode Consulting allows us to challenge and test our own processes.”
Nick Dodds, Joint Managing Director at Medisoft.
Summary
As part of the Heidelberg Engineering Group of Companies, Medisoft pioneers data technologies to optimise ophthalmic solutions and support learning that advances research and empowers eyecare professionals who want to improve the holistic health of patients.
Medisoft's Mission is to drive optimised patient care and advancements in ophthalmology via seamlessly integrated software, data solutions and research.
Their Vision is to become the most trusted supplier of ophthalmic clinical research and electronic medical records.
Medisight
Building on more than 25 years’ experience and feedback from ophthalmologists and their teams, mediSIGHT is the latest generation of their industry-leading Electronic Medical Records (EMR) platform.
Shared Care Solutions
Using Medisoft's shared care portals supports the NHS long term plan to “boost out-of-hospital care” and GIRFT best practice guidance allowing shared care with community optometrists
Audit Suite
Audit Suite is Medisoft's groundbreaking reporting module designed to provide insights into the clinical outcomes of ophthalmology patients.
Clinical Data Services
Their Data Services Team provides full-service data anonymisation, extraction, and analytical services to leverage the wealth of structured data collected in the mediSIGHT EMR for real world evidence studies.
Medisight Cloud
mediSIGHT Cloud enables healthcare organisations to retain the full capability of mediSIGHT while benefiting from a secure, scalable and professionally managed cloud infrastructure.
What were the issues
Critical to achieving their vision is assuring their clients, typically health services across the UK, Europe & beyond, that their platform is secure. As such Medisoft is working towards ISO 27001, information security management, having been certified to the quality standard for over a decade.
Under the Medical Device Regulations (MDR) , elements of the MediSIGHT platform are considered Class II devices, hence working to ISO 13485, Quality management systems — Requirements for regulatory purposes.
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