Friends -

    The links below are classics. Please also check out the treasures I've listed in the pages on the left menu.

- Nancy 

   FDA

Compliance Program Guidance Manual

Device Advice

FDA Warning Letters

   COMPLIANCE

Points To Consider for the QSIT Design Controls Subsystem

Points to Consider for  the QSIT Corrective and Preventive Actions (CAPA) Subsystem

Points to Consider for the QSIT Management Controls Subsystem

Code of Ethics for Interactions  with Health Care Professionals

Global Harmonization Task Force

   INSPECTION

Guide to Inspection of Quality Systems

Inspections Operations Manual

Laws Enforced By the Food and Drug Administration

ORA Field Management Directive

   QUALITY

Correspondence Between ISO 13485 and the Quality System Regulation

How to Avoid an MDR Disaster: Set Up An Effective Reporting System

Implementation of Risk Management Principles Within a Quality System

Quality System Regulation

   ASSISTANCE

FOI Services

Medical Device Link

Optimizing FDA Compliance

QMS Consulting