With Medical Device Suite, you can
- optimize your ISO 14971 Risk Management Analysis consistently from the Regulatory Affairs point of view
- optimize the functional analysis and FMEA studies done by the same device design and manufacturing process designers
- and ensure sustainable consistency.
According to your context and needs, you are free to use only one module or to capitalize sharing, data consistency and automations between the various modules.
Considerable Time Saving
- Easier team facilitation and motivation through the direct use during work sessions.
- Proven trade-specific references, including the CETIM application guide for ISO 14971 in the view of Regulatory Affairs.
- Successful capitalization thanks to the ability to integrate your references and create your generic studies, enriching along with new projects.
- Automated print of specifications, Design and/or Process FMEA studies, risk management report, current action summary, and risk status changes over time.
- Streamlined action plan management.
Sustainable and collaborative information system
Your regulatory and design-related methodological data are structured, centralized, shared and can be connected to your PDM solutions. The management of rights and roles allows each person to only view his / her personal information.
Quality and logs (audit trail)
The automatic logging of changes on each data proves that periodic updates are done. It also eases the identification of what has been changed since the previous meeting or audit or since the placing on the market (post-production data), for instance.
Return on investment
Our clients give evidence they benefit from a clear ROI on cost and cycle length related to the development of their medical devices, as well as to the ISO 14971 administrative handling.
The multilingual management of the data also enables to reduce the translation costs to the only specific elements of each project.
Medical Device Suite Modules
Herafter the several modules of Medical Device Suite that share risk and design date:
- RM 14971 : Risk Management according to ISO 14971:2013
- TDC Need captures the voice of the customer and structures the “actual” need using functional analysis
- TDC Structure crosses needs and technical breakdown structure or optimizes the (re-)design
- TDC FMEA deals with the Product FMEA and/or Process FMEA studies, monitoring plans,
manufacturing synoptic overview, job description…
- TDC FTA handles Fault Tree Analysis
Medical Device Suite offers by default the approaches that stem from standards, expertise and best practice in numerous industries in more than 20 years accompanying the industry actors.