Professional Documents
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ISO13485 Differences
ISO13485 Differences
Susan Murphy
European Medical Device Operations Manager
So…Where Are We Now?
Definitions
Shall
Will
Used to express
desire
choice
willingness
consent
or in negative constructions refusal
Present
(*Most of the World)
ISO 13485:2003:
Medical Devices – Quality Management Systems,
Requirements For Regulatory Purposes
Present – Europe
(*Harmonized EU Version)
4.1 General
4.1.1 document the role(s) of the organization.
4.1.2 determine and apply the processes needed and apply a risk
based approach to the control of those processes
(*New)
What’s New In 2016?
Section 5: Management Responsibility
(*New sub-clause)
What’s New In 2016?
Section 7: Product Realization
7.2.3 – Communication:
(*New sub-clause)
What’s New In 2016?
Section 7.3: Design and Development
(*New sub-clause)
What’s New In 2016?
Section 7.4: Purchasing
7.5.8 – Identification
8.2.1 – Feedback
This feedback process shall include provisions to gather data
from production as well as post-production activities
What’s New In 2016?
Section 8: Measurement, Analysis and Improvement
(*NEW sub-clause)
What’s New In 2016?
Section 8: Measurement, Analysis and Improvement
*8.3.1 – General
The evaluation of nonconformity shall include a determination of
the need for an investigation and notification of any external
party responsible for the nonconformity.
*8.3.2 –
Actions in response to nonconforming product detected before
delivery
Records of actions relating to the issuance of advisory notices
shall be maintained
(*New sub-clause)
What’s New In 2016?
Section 8: Measurement, Analysis and Improvement
GCL-25-01
NSAI Technical Questionnaire
MDR: Major Changes and
Impact on Industry
Colm O’Rourke
NSAI- Medical Devices
colm.orourke@nsai.ie
@NSAI_Medical
What we will cover
Directive Regulation
Outcome of investigations by FVO
and Joint Commission
80
Notified Bodies
56
What is a Notified Body?
NSAI
BSI
TUV
SGS
LNE G/MED
LRQA
DEKRA
MDR (Medical Device Regulation) –
What is it?
• More detailed requirements on everything:
previous MD Directive 60+ pages vs. new
regulation of 566 pages
• Classification
MDR – Grandfathering
• Contract in place?
• Disproportionately effect
start-ups/smaller companies
• Stricter competency
requirements
• Time to Market
• Clinical data
• Approval process
colm.orourke@nsai.ie
@NSAI_Medical
Questions?