MEDICAL DEVICE MATTERS:

Regulatory compliance

21 CFR Part 11

cGMP CFR820

ISO 13485

Recall

Your Business. Our World.

MEDICAL DEVICES

The medical device industry has its unique demands—cost management, regulatory compliance and more. It’s incumbent upon you to deliver results, but moving to new software or updating what you already have can be a great disruption and have an effect on the bottom line. EpiCenter’s team comes equipped with years of manufacturing experience and greatly eases the transition. We start with your people and what they need to do their jobs more efficiently. And then we make the software work for you.

 

What keeps you up at night?

 

Can your system give complete traceability of every serial number and lot? Can you turn on a dime to respond to regulatory requests or last-minute audits? How much strain do administrative tasks put on your people and the business? The solution starts with a conversation. Let’s talk soon.

MEDICAL DEVICE MUST HAVES

Pre-Packaged Validation Scripts

Manufacturer's Part Number

Device Used/Change Logs Validation

Consignment Inventory

Electronic Signature in More Places

ISO 13485 and 9001 standards

Current Good Manufacturing Practice (CGMP)

CFR and FDA requirements

Secure electronic signature and document control to comply with 21 CFR Part 11

Non-conforming product review and tracking

Comprehensive Corrective Action/Preventive Action (CAPA) and Process/Product PQ functionality

Product Lifecycle Management