Your Job

Regulatory Affairs Responsible and Designers : The Software Modules You Need For Your Medical Device.

Training

Our team of trainers aims to allow you to implement Medical Device Suite and its different modules, in the best conditions of appropriation. Our team of trainers aims to allow you to implement Medical Device Suite and its different modules, in the best conditions of...

Computerization Audit

Optimise your Information System ! Our Computerization Audit : The Knowllence team of consultants has the expertise to audit your current habits in terms of ISO 14971 Risk Management and in terms of design and manufacturing process, in order to help you prepare the...

Software for Medical Device designers

Medical Device Suite proposes optional software for functional analysis (needs, technical) and for Design and Process FMEAs. Quality in Design and Manufacturing of Medical Device How to capture the customer voice, the needs and the internal constraints, identify and...

Software for Regulatory Affairs

The right risk management according to the EN ISO 14971:2013 is one of the issues of the "Regulatory affairs" function. Risk Management 14971 Software is the essential tool to facilitate your daily work! ISO 14971 Software You Need ! Risk Management RM 14971 allows...

How to boost your Regulatory Monitoring for Medical Device ?

Lots of information are available on the web sites of the official authorities, but it seems interesting to point out the existence of French newsletter arriving automatically in your mailbox .   L'essentiel du TÜV TÜV Rheinland offers to download a certain number of...

ISO 14971 Software with Native Audit Trail

Medical Device Suite manages automatically the history of all changes on each of data. Our software offers you a total traceability without any effort about date, time, author, type of actions. You can then know at any time who did a change, when and where in your...

Webinar: FMEA Software, how to pilot your quality in manufacturing

  Pilot the robustness of your industrialization We propose you a demonstration (in French) of the FMEA software of Medical Device Suite: In 30 minutes, you will see how our software can help you in the your quality in manufacturing thanks to Process FMEA process,...

Stand at the ISIFC exhibition (15 & 16 sept. Besançon)

Knowllence will be partner of the exhibition and training about Medical Device, organized by ISIFC University, on 15 and 16 September in Besançon, France. We will have a n exhibition stand to answer your questions about our software for ISO 14971 risk management and...

ISO 14971 Risk Management Software Module

Meant for the Regulatory Affairs, RM 14971 software is dedicated to Risk Management on Medical Device, according to ISO 14971:2013, and generate automatically the Risk Management Report (Chap. 8) .   An ISO 14971 Software Integrating Repositories This software...

Medical Device Suite : General Information

Medical Device Suite is a software package to pilot the ISO 14971 risk management and the design of your medical device. With Medical Device Suite, you can optimize your ISO 14971 Risk Management Analysis consistently from the Regulatory Affairs point of view optimize...

Fault Tree Analysis with FTA Software Module

Module of Medical Device Suite, TDC FTA is a fault tree analysis software that guarantees the calculation accuracy and the methodological links with risk management. It helps to have the “realiability and safety” view of your medical device. Fault Tree Analysis...

Design FMEAs and Process FMEAs with our FMEA software module

Belonging to Medical Device Suite, our FMEA software allows to organize, automate, and capitalize all data concerning your medical device in terms of Design and Process FMEA studies, flowcharts, job instructions, etc  FMEA Software :  Both Standard and Customizable...

Functional Analysis of Needs, Functional Specifications

TDC Need captures the voice of the customer and structures the "actual" need using functional analysis and printing Functional Performance Specifications. A Formalized and Standardized Approach Need software to ask all the right questions at the start of a "Medical...

Substantial Benefits for Team and Compagny

Medical Device Suite brings benefits both to each of its users, and at the level of the enterprise. Benefits for Project Teams You are free to buy only the modules that you really need: functional analysis, ISO 14971, Design FMEA and/or Process FMEA, etc. Each team...

Next Step ?

Our team remains at your entire disposal for any precision or to schedule a demonstration when you want.

Call MeAsk for a DemoAsk for a Price



Events A Demo ? Price?
Share This