Safe, compliant medical software
INRstar was designed specifically to improve patient safety, whilst making your anticoagulation service as efficient and effective as possible. Our team of experts work hard to ensure that our software complies with the European Medical Device Directive (93/42/EEC) so that you can meet all clinical risk assessment compliance obligations.
Should anticoagulation support software be CE marked?
Anticoagulant support software is classed as a Medical Device by the Medicines Healthcare Regulatory Agency. This means that all software must be CE marked before it can be sold or purchased in the UK.
INRstar has achieved ISO 13485 quality standard for medical devices and conforms to the legal requirements of the UK and EU Medical Device Directive (93/42/EEC). As a CE mark approved product INRstar is proven to meet safety legislation and is fully data compliant and meets the requirements of CQC Practice audits.
Safety built in:
- Clinically risk assessed by medical professionals
- Online education which includes certificates and training records
- Out of the box reports so that you can follow NICE guidelines on anticoagulation management and meet National Patient Safety Agency (NPSA) compliance
- Transfer of INRstar patient records from Secondary into Primary Care and vice versa to manage continuity of care and its associated safety issues