We will personally review your request and help you build a plan for success. 
 
When you need several change and impact analysis, we can deliver them digitally in ColabON's tool.
 
By purchasing this product, we will create a custom change and impact analysis just for your needs. 
 
If you give us some informations about your medical device and the old assessement, we will address your unique request and give you my best recommendations!
 
Please let us know, which standard or regulations you'd like to assess: MDR, IVDR, MDSAP... 
 
We will deliver:
OLD and New Data Set incl. Licences Cost (up to 200 CHF)
Automated Data Mapping on clause level: e.g. 4.1 to 4.3
 
Change Description: Change Status
[NONE]
[SIMILAR],
[CHANGE],
[NEW_REQUIREMENT]
[DELETED_REQUIREMENT]
 
APPLICABLITY Assessment 
IF you like, we can add the Applicability of your OLD Interpretation to the analysis.
The impact for INFORMATIVE Clauses will be set to NO impact. 
 
Add EVIDENCES to the NEW Standard interpreation 
With ColabON, you're not just getting the difference. You get the difference, the  applicablity, and the tracebility. ColabON is a compliance system not a Notification system. 
 
CSV or Excel Report
 
This price is for 20 pages of a standard or a regulation. The price includes copy licence fees, digitalization of the data, data mapping and change description.