mdsap experience in the pilot program - massmedic experience in the pilot program ......
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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
TÜV SÜD
Performing audit challenges: audit sequence
14-Feb-13 Corporate Presentation Slide 6
Big manufacturer
Complex manufacturer
Large Audit Teams
TÜV SÜD
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
TÜV SÜD
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.
tborsai@tuvam.com
TÜV SÜD Product Service GmbH
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