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Proactive / ISO 13485 Software

ISO 13485 Software for Medical Devices

Established ISO 13485 compliance software for medical device quality management systems. Policies and procedures including technical documentation required by the MHRA for the registration of Class I, IIa, IIb, or II devices. ISO 13485 QMS managed centrally and effectively using ProActive.

ISO 13485 Software for Medical Devices QMS - Your dedicated Quality Management Software

ProActive ISO 13485 Software makes the process of achieving ISO 13485 certification and ongoing QMS maintenance both simple and cost effective. Accessible from your desktop or remotely from mobile devices ProActive provides a centralised tool for the tracking and management your Medical Device quality management systems.

ProActive ISO software facilitates improved quality performance and first time ISO 13485 certification, for your medical device/s irrespective of devices class.

In the office, on the shop-floor or at a supplier's location ProActive provides rapid access to your ISO 13485 QMS.

ProActive ISO 13485 management software provides more functionality and value, click the software features link below to learn more.

FIND OUT MORE ABOUT OUR ISO 13485 SOFTWARE FEATURES

Having tried several eQMS systems and being unhappy with their performance a supplier introduced me to ProActive ISO Management software and from day one I knew I had found an eQMS that was simple to use and suited our company’s needs.

Oraldent

ProActive Medical Device QMS software adds value by

Providing an easy to use centralised tool for retention of medical device QMS documentation including technical documentation
Provide a centralised tool for tracking and alerting required QMS activities
Helping your team to address non-conformities and apply CAPA based corrective actions
Providing additional QMS functionality compared with other segmented and more expensive software packages
Monitoring outstanding QMS performance issues using dashboard indicators, email alerts and email warnings
Retaining meaningful quality objectives and action plans
Assisting with QMS and associated risk management documentation up to date
Complying with all appropriate legal and other compliance requirements including the MHRA
Maintaining equipment and calibration records, issuing calibration alerts to accountable team members in advance of calibration due dates
Ensuring effective internal and external audit schedules, audits and corrective action records are in place and tracked
Performance measurement and improvement tools, top loss and KPI focussed

Leading

ISO 13485 Quality Management Software

Leading ISO 13485 Compliance Software, the choice of medical device providers serious about medical device quality systems and effectively maintaining ISO 13485 certification.

Software Features

ProActive ISO 13485 QMS benefits

Benefits frequently enjoyed by ProActive ISO 13485 clients:

First time ISO 13458:2016 certification
MHRA product registration for Class I, IIa, IIb, or II devices
Easy QMS access and use
UKCA and/or CE product marking
Reduced process risks
Reduced waste
Reduced quality non conformities
Effective problem solving
Increased quality awareness
Increased QMS participation
Reduced operating costs
System generated alerts for critical QMS activities
Competence advantage
Tender barrier removal
Easy integration with ISO 9001, ISO 14001 and ISO 45001.

Discover how ProActive can help deliver ISO 13485 Certification to your Business

Enjoy a commitment free demo from one of our ISO 13485 Consultants, then decide which Software Package best suits your Business.

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