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

Transcript of MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ......

Page 1: MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ... Manufacturer’s challenges ... Number of Tasks Time per Process (hh:mm)

MDSAP Experience

in the pilot program

TÜV SÜD Product Service

Tamas Borsai

TÜV SÜD Product Service

Dec 2016

Page 2: MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ... Manufacturer’s challenges ... Number of Tasks Time per Process (hh:mm)

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

Page 3: MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ... Manufacturer’s challenges ... Number of Tasks Time per Process (hh:mm)

TÜV SÜD

Manufacturer’s challenges

Audit organization's experience & challenges

Best practices for preparation

MDSAP experience

14-Feb-13 Corporate Presentation Slide 3

Page 4: MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ... Manufacturer’s challenges ... Number of Tasks Time per Process (hh:mm)

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

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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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TÜV SÜD

Performing audit challenges: audit sequence

14-Feb-13 Corporate Presentation Slide 6

Big manufacturer

Complex manufacturer

Large Audit Teams

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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

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TÜV SÜD

Audit organization experience: audit reporting & findings

12/12/2016 Corporate Presentation Slide 8

Report Templates

Grading of findings

Page 9: MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ... Manufacturer’s challenges ... Number of Tasks Time per Process (hh:mm)

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

Page 10: MDSAP Experience in the pilot program - MassMEDIC Experience in the pilot program ... Manufacturer’s challenges ... Number of Tasks Time per Process (hh:mm)

TÜV SÜD

Tamas Borsai

Division Manager, Medical and Health Services

TÜV SÜD America Inc.

[email protected]

TÜV SÜD Product Service GmbH


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