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ISO 13485:2016 for "Dummies"
ISO 13485:2016 for YOUR SMALL Business
MDSAP for Executives
MDSAP - The 12 Step Program to Implementing a Compliant System
MDSAP - Implementation Tools and Timelines
MDSAP for YOUR SMALL Business
21 CFR 820 for "Dummies"
21 CFR 820 for Executives
EU MDR for Executives
EU MDR - Implementation Tools and Timelines
What is the GSPR for European Compliance and How to Use it as a TOOL for Compliance
Annually Required GMP/QSR Training for Medical Device Companies of ALL Sizes
ISO 13485:2016 Lead Auditor Training
ISO 13485:2016 Internal Auditor Training
MDSAP Lead Auditor Training
MDSAP Internal Auditor Training
21 CFR 820 GMP/QMS Internal Auditor / Inspector Training
How to perform a Regulatory Gap Analysis of Your QMS/QSR
CAPA for Beginners: Simple, Easy and Compliant (21 CFR 820 and ISO 13485:2016
CAPA for Intermediate
CAPA for the CAPA Coordinator & CAPA Management
CAPA Remediation - Who to UNCOMPLICATE Your CAPA system and still be compliant.
CAPA - Verification of Effectiveness
CAPA Tracking: Simple, Easy, Effective and Compliant
CAPA: Hands-on Training with Managers and CAPA Owners
Customize Hands-on and On-site Training
Getting to the REAL ROOT of the Problem
Root Cause and Nonconforming Materials
Using FMEA's in Product Development & Device Changes
Medical Device Risk Assessments Made Easy and Compliant
ISO 14971:2012 / 2019 - Applying is in Your QMS
Quality Management System Risk Assessment to Comply with ISO 13485:2016
Using FMEA's in Product Development & Device Changes
Medical Device Risk Assessments Made Easy and Compliant
Design and Development Control for Dummies
Design and Development Control for Executives
Hands-on Design and Development Tools to Properly Document Your Project for Compliance and Speed
How to Prepare a Design History File (DHF) / Medical Device File (MDF)
How to Prepare a Technical File / Technical Documentation for EU MDR Compliance
How to Plan the Regulatory Requirements Into Your Project for BEST RESULTs
How to Implement Design & Development Controls into Your QMS
How to Utilize a CORE TEAM to Maximize Speed to Market & Regulatory Compliance
QMS-101
QMS Implementation - How to Customize and Right-size Your QMS to ADD VALUE and Compliance
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