ISO 13485:2016 QMS for MedDev

Medical devices - Quality management systems - Requirements for regulatory purposes. NOW DESIGNED TO BE USED BY SUPPLIERS TO MEDDEV ALSO. 

ISO 13000 Risk Management

ISO 31000:2009, Risk management – Principles and guidelines, provides principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector.

ISO/IEC 31010:2009

IEC 31010:2009 is a dual logo IEC/ISO, single prefix IEC, supporting standard for ISO 31000 and provides guidance on selection and application of systematic techniques for risk assessment.


Risk Management for Pharma

See the best of all risk management standards and techniques.  What works today for Notified Bodies and what is expected tomorrow.
1 Day Course Available on Demand

Risk Tools - Which to Use -

Preliminary RIsk Assessments
Project Risk Assessments
1-2 Day Course Available On Demand

ISO 14971 Risk Management for MedDev

What's in your Risk Management File?
Risk Procedure / SOP
Risk Plan
Risk Assessment
Risk Evaluation & Criteria
Supporting Data
Risk Benefit Analysis
Risk Report
1-2 Day Available On Demand

Root Cause Analysis

Root Cause Analysis should not be taken lightly and is often just that.  Inadequate tools, lack of resources.  We've heard the excuses.  Let's smarten up and get results.
1/2 Day available Weekly or On-Demand

Innovation Design

Aulet's 24 Steps to Disciplined Entrepreneur lends its self well to Intrapreneurship within industry.  Get the most out of design teams. 

Design Teams can be creative again and deliver at the same time. 

Available on Demand.

CSV & Validation

A difficult area without the right expertise.  It's not difficult when you understand the requirements, though a heft piece of work.  We'll show you how.
Available on Demand
Risk Management