Library

Acceptance Sampling

Understanding Metrics

Process Metrics

Process Metrics (March, 2009 – 6 Pages)

CAPA Systems

FDA Information

Managing the Supply Chain

Medical Device Regulations

Initial Importer

Initial Importer (November, 2016 – 2 Pages)

Changes to QSR

Changes to QSR (December, 2010 – 6 Pages)

Laboratory Developed Tests

In Vitro Diagnostic Directive

Restrictions on Hazardous Substances (RoHS)

RoHS Q&A

RoHS Q&A (September, 2010 – 3 Pages)

Risk Management for Medical Devices

Statistical Tolerancing

Statistical Distributions

Usability Engineering

Warning Letters

ISO 13485:2016

UDI

EU-MDR

FDARA

Medical Device Excise Tax

Medical Device Reports-Part 803

Preparing for eMDR

Preparing for eMDR (October, 2017 – 2 Pages)

UDI in the US

Equipment Maintenance

Quality Auditing

Medical Device Risk Management

Employee Competence and Training

MDSAP

Corrections & Removals-Part 806 Aisle 110

Data Analysis