Consider the device THERAPY not just the device.
A broader CER - an overall risk benefit analysis.
Start your literature review as an INPUT process.
LINK your CER output to your COMPLAINTS.
Maintenance of the CER and POSTMARKET SURVEILLANCE.
White papers for the SALES TEAM.
Not Just an EU / ISO Thing.
The Case for Outsourcing with Ironbarque.
Medical Device Consulting Regulatory Quality Complaince
(c) Ironbarque Corporation 2016