mdsap experience in the pilot program - massmedic experience in the pilot program ......
TRANSCRIPT
MDSAP Experience
in the pilot program
TÜV SÜD Product Service
Tamas Borsai
TÜV SÜD Product Service
Dec 2016
TÜV SÜD Product Service Slide 2 March 2014 New Clinical Data Requirements in the EU
ISO 13485:2016
MDSAP
MDR / IVDR
2016 03 2019 04
ISO 9001:2015
2015 09 2018 10
2017 ?? 2024
2017 01 2018 12
2019
Time Table – The big picture
TÜV SÜD
Manufacturer’s challenges
Audit organization's experience & challenges
Best practices for preparation
MDSAP experience
14-Feb-13 Corporate Presentation Slide 3
QMS general, manufacturer challenge: specific requirements
TÜV SÜD
BrazilAnvisa
RDC 16/2013
CanadaHealth Canada
CanMDR
USAFDA
21 CFR Part 820
EuropeConformity assessment procedures
according to AIMDD, MDD, IVDD
AustraliaTGA
TG(MD)R
JapanMHLW / PMDA
MHLW MO169
Which requirements / which facilities? •Australia & Canada: “legal manufacturer”
•Brazil: manufacturing finished device
•USA: subject to establishment registration
•Japan: manufacturing Site
TÜV SÜD
Preparation and planning challenge: audit time
12/12/2016 Corporate Presentation Slide 5
MDSAP ProcessNumber of Tasks
Time per Process(hh:mm)
Management 11 6:36
Market Authorization & Facility Registration
3 1:45
Measurement Analysis & Improvement
16 10:08
Adverse Events & Advisory Notice Reporting
2 1:16
Design & Development 17 5:57
Production & Service Controls
29 21:16
Purchasing 16 4:00
Total 9450:58
(6Audit Days + 3h)
Multisite
Small manufacturer
Surveillance
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Performing audit challenges: audit sequence
14-Feb-13 Corporate Presentation Slide 6
Big manufacturer
Complex manufacturer
Large Audit Teams
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Finding rating and escalation
Timelines for corrections / CAPA
Report availability to regulators
Manufacturer challenge: report & findings
14-Feb-13 Corporate Presentation Slide 7
TÜV SÜD
Audit organization experience: audit reporting & findings
12/12/2016 Corporate Presentation Slide 8
Report Templates
Grading of findings
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Summary, best practice & preparation
12/12/2016 Corporate Presentation Slide 9
Thorough preparation
Diligent internal audit
Availability of resources before, during and after audit
TÜV SÜD
Tamas Borsai
Division Manager, Medical and Health Services
TÜV SÜD America Inc.
TÜV SÜD Product Service GmbH