SOPs_Available

SOPs_Available

 

INTRODUCTORY OFFER

 

TO AQUAINT YOU WITH THE VALUE OF THESE SOP'S THE FIRST SOP WILL BE FREE.

Choose any SOP. Enter the SOP name or number and  "INTRODUCTORY OFFER" in an email to sales@meddeviceadvisors.com. The SOP will be emailed to you.

 

NOT SURE WHAT SOP'S YOU NEED?

CALL (804-615-2893) OR EMAIL (info@meddeviceadvisors.com) OUR OFFICE FOR A FREE NO OBLIGATION DISCUSSION WITH A CONSULTANT about any SOP.

 

SOP CATALOG (click to view detail)

When you buy a SOP group you get 2 hours of free telephone consulting time to help you implement the SOP's.

 


GENERAL QUALITY SYSTEM REQUIREMENTS SOP GROUP

This SOP group describes procedures necessary for a compliant Quality System including how to plan for a FDA audit and respond to 483's and warning letters.

DOCUMENT CONTROLS SOP GROUP

These SOP's describe procedures for compliant control of documents including laboratory notebooks and partner company documents.

SOFTWARE DEVELOPMENT & VALIDATION SOP GROUP

This SOP group contains procedures for the control of software development and validation including off the shelf software and 21 CFR part 11 validation.

ACCEPTANCE ACTIVITIES SOP GROUP

These SOP's describe procedures to control incoming material including control of nonconforming product.

DESIGN CONTROLS SOP GROUP

This SOP group contains procedures that will assure that your product development work is conducted in conformance with FDA/ISO requirements including verification and validation.

CAPA SOP GROUP

This SOP group comprises a compliant CAPA program including SOP's for recalls, MDR's and post distribution product monitoring.

RISK MANAGEMENT SOP GROUP

This SOP group contains procedures for a compliant risk management program including Hazard Analysis following ISO14971, FMEA and critical manufacturing operations analysis.

PROCESS VALIDATION SOP GROUP

These SOP's describe a compliant process validation program from FAT through IQ,OQ and PQ. Validation deviation handling is included.

HUMAN FACTORS & USABILITY SOP GROUP

This SOP group will allow you to create a compliant program following ISO62366 and the 2016 FDA guidance.

SUPPLIER CONTROLS SOP GROUP

This SOP group describes procedures for controlling purchasing and vendor/ contract manufacurer activities including audits and control of changes traveling between company and vendor.