Tailored to your company portfolio, this software platform monitors all medical device standards (published and in development) that are relevant for your devices. Save time searching by using one consolidated information resource.
- Centralized and up-to-date medical device standards information on your complete portfolio
- Identification of all applicable standards and detailed follow-up of the development or revision process
- Monthly e-mail notification of significant changes
- A tracking system to prove compliance and adherence to quality systems and audits
- Full consultancy service back-up on medical device standards development and standards purchase
Save valuable time!
Standards monitoring is business critical, but time-consuming. Status changes, amendments or additional standard initiatives need to be evaluated for impact and communicated internally.
normScan monitors the development horizon continually, and identifies changes promptly. Additionally, MDCPartners’ consultancy can assist to advise any medical device manufacturer with the necessary information on impending standards development that may impinge on a device’s compliance status.
on medical device standards and guidelines
normScan collates all standards data from international (ISO, IEC), European (CEN, DIN, BSI, etc.) North American (AAMI, ASTM, ANSI) and many other standards organizations and institutes, as well as guidance documents like FDA and formal guidelines that may have applicability for your devices. normScan spots data points that are practically relevant and visualizes the data on a user-friendly website that can be accessed by your company’s stakeholders.
In contrast to other standards tracking services, normScan is the result of your specific device portfolio analysis. Our software scans the standardization horizon continuously for all relevant data (based on device class, intended use and materials), eliminating guessing and time-consuming searches.