Is your Risk Management System Effective? Are you risks reduced? Do you have less complaints? Do you have less NC's because of Risk Management?

1. Risk Management within Medical Devices
MScSED - Module: MCT626
Researcher: Niamh St John Lynch
Advisor: Dr Owen Molloy
Date: 04 May 2016

2. Experience
Qualifications / Experience
Quality Manager
 J&J, Boston Scientific, Beckman
Coulter / Danaher, Merit Medical,
Bioniche / Mylan, Phardiag /
Menarini Group
20 Years in IT, Pharmaceutical
and Medical Devices
BSc Cognitive Science (Hons)
MSc Neuropharmacology
Certified to ISO 14971:2016
Certified to ISO 13485:2016
Certified to GMP/GDP/RP
Niamh Lynch (nee St John)

3. Contents
Background
Definitions
Introduction
Problem Overview
Research Question
Literature Review
Research Methodology
Conclusion

4. Requirements Relevance?
Background
Risk management is
central to all Medical
Device manufacturers and
with the changes to ISO
14971:2012 and more
recently ISO 13485:2016
All Medical Device
companies need to
review their approach

5. ISO 14971 Risk Management
Risk Plan
Risk
Analysis
Risk
Evaluation
Risk
Control
Effectivene
ss
Monitoring
Risk
Acceptabilit
y
Risk Report
Risk Benefit
Analysis
ISO
14971:2012
Risk Plan
Risk
Analysis
Risk
Evaluation
Risk
Control
Effectivene
ss
monitoring
of controls
Risk Report
ISO
14971:2007/20
09
Risk
Analysis
Risk
Evaluation
Risk
Control
ISO
14971:2001
Risk
Assessment
Only
ISO 14971-
1:1998
21 CFR Part
820 required
for device
modification
includes
Design
Control and
Validation
including
labelling and
packaging
QSR 1996
Medical
Device
Amendment
Class III
medical
devices to
go through
PMA
FDA GMP
1976

6. Definition of Risk
“the combination of the probability of
occurrence of harm and the severity
of that harm” Q9 (2006)

7. Definition of Risk Management
“the systematic application of quality
management policies, procedures, and
practices to the tasks of assessing,
controlling, communicating, and reviewing
risk”, Q9 (2006).

8. Why Perform Risk Management?
Reduce Risk to Patients
Reduce Risk to Business reduce cost
Risk management attempts to identify, measure,
mitigate or control risks, which as we defined above,
are the opportunity for loss or injury in order to
protect the public from harm arising from new
medical devices or changes to existing medical
devices

9. What is a Medical Device?
 Medical Device - “Any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator, software, material or
other similar or related article, intended by the manufacturer to be
used, alone or in combination for human beings for one or more of
the specific purpose(s) of the following:
 Diagnosis, prevention, monitoring, treatment or alleviation of
disease;
 Diagnosis, monitoring, treatment, alleviation of or compensation for
an injury;
 Investigation, replacement, modification, or support of the anatomy
or of a physiological process;
 Supporting or sustaining life
 Control of conception
 Disinfection of medical devices
 Providing information for medical purposes by means of in vitro
examination of specimens derived from the human body; and which
does not achieve its primary intended action or on the human body
by pharmacological, immunological or metabolic means, but which

10. Problem Overview
 Patient Harm, Injury and Death continue to
occur
 Product Recalls and Failures continue
 Risk Management System Requirements
require ‘robust’ risk techniques
 Risk Management Systems continue to be
difficult to maintain
 Risk Management Systems are for the most
part, not integrated within it’s QMS
 FMEA is main tool used in Medical Devices –
not robust enough to identify all risk

11. Literature Review
Lit Review Demonstrates:
FMEA is the tool of choice for
manufacturing, manufacturing services and
suppliers to the industry.
Ref. Dumbrique, R. (2010). Implementation of
Risk Management in the Medical Device
Industry. Master’s Theses Paper 3855. San
Jose State University. SJSU Scholar Works

12. Research Question
Two key questions :
Do Medical Device companies continue to rely
heavily on Failure Modes and Effects Analysis
(FMEA) as the primary tool for risk assessment
(ref. Lopez, et al (2010), Kamm (2005) and Lu Gan (2012)?
Does the FMEA adequately support Risk
Management throughout the full lifecycle of the
Product Development Process to meet relevant
Medical Device standards, ISO 13485:2016 and
ISO 14971:2012?

13. Failure Modes Effects Analysis

14. FMEA Limitations
Some of the limitations of the FMEA listed by McDowall
(2005 and Gan, 2011) include:
Components can be tedious and difficult to analyze
when part of complex systems
Compound failure effects cannot be analyzed
Cost and time consuming, unless carefully controlled
Successful completion requires expertise, experience
and good team skills
Incorporating all possible factors influencing the
system, such as human errors can result in lengthy
analysis, difficult to manage.
Data redundancies can be a problem and is time
consuming

15. How Can Technology Help?
A software risk management tool is
proposed to overcome these significant
problems within the industry.
The aim for the software tool suggested is
to streamline the process, create
efficiencies within the Quality
Management System (QMS), reduce real
risk to the business and ensure
compliance to the relevant regulatory
standards and authorities.

16. Research Methodology
A combination of methodologies are required
to conduct this research:
Content Analysis
Literature Review
Data Surveys for current status
Experimental Research & Development relevant
architectural design

17. Useful Websites
 ASQ: http://www.asq.org
 FDA: http://www.fda.gov ; http://www.21cfrpart11.com
 ICH: http://www.ich.org
 IEE: http://www.iee.org
 ISPE: http://www.ispe.org/gamp/
 BSI: http://www.bsi-global.com
 NIST: http://csrc.nist.gov/publications/nistpubs/index.html
 WHO: http://www.WHO.org
 EU: http://ec.europa.eu
 GHTF: http://ghtf.org now http://www.imdrf.org

18. Q&A
Go Raith Maith Agat
Thank You