181122 Webinar - MDSAP World of Opportunity · 2019. 6. 28. · î ì í ô v Á } } ] } u ] o Á...

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© 2018 Brandwood Biomedical www.brandwoodbiomedical.com © 2018 Brandwood Biomedical www.brandwoodbiomedical.com Why MDSAP Opens a World of Possibility MDSAP Medical Device Single Audit Program T.J. Thiel LIVE Webinar November 2018

Transcript of 181122 Webinar - MDSAP World of Opportunity · 2019. 6. 28. · î ì í ô v Á } } ] } u ] o Á...

Page 1: 181122 Webinar - MDSAP World of Opportunity · 2019. 6. 28. · î ì í ô v Á } } ] } u ] o Á Á Á x v Á } } ] } u ] o x } u,qlwldo uhylhzv ri wkh 0'6$3 surjudp dqg lwv lpsohphqwdwlrq

© 2018 Brandwood Biomedical www.brandwoodbiomedical.com© 2018 Brandwood Biomedical www.brandwoodbiomedical.com

Why MDSAP Opens a World of Possibility

MDSAPMedical Device Single Audit Program

T.J. Thiel

LIVE Webinar

November 2018

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What is MDSAP?

Participating Countries

Eligible Auditing Organisations

Auditing: ISO 13485:2016 and MDSAP compared

Documentation Differences

Audit Documentation Requirements

Agenda

Benefits of MDSAP

Initial Reviews

Questions

Conclusion

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The Medical Device Single Audit Program allows an

MDSAP recognized Auditing Organization to conduct a

single regulatory audit of a medical device manufacturer

that satisfies the relevant requirements of the

regulatory authorities participating in the program.

What is MDSAP?

MDSAPMedical Device Single Audit Program

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TGA ANVISA Health Canada

PMDA FDA

Countries Participating in MDSAP

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Organisations authorised to conduct MDSAP Audits.

Eligible Auditing Organisations

Current list at: https://www.fda.gov/downloads/MedicalDevices/Internatio

nalPrograms/MDSAPPilot/UCM429978.pdf

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Process and basic requirements for ISO 13485:2016 and MDSAP are aligned.

BUT significant differences include:

Auditing: ISO 13485:2016 and MDSAP Compared

Inclusion of geography-specific

information

MDSAP uses a point-based

nonconformity grading system

MDSAP Audits require two Stages

in the initial assessment

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Aligned with the GHTF’s Quality management system - Medical devices -Nonconformity Grading System for Regulatory Purposes and Information Exchange.

Add 1 point for absence of a process or release of Non-conforming MDs.

Auditing: ISO 13485:2016 and MDSAP ComparedNonconformity Grading

Direct 3 4

Indirect 1 2

First RepeatOccurrence

QMS Impact

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Pre-Market Regulatory

Post-Market Regulatory

Recalls and Product Notifications

Design and Development

Design Changes

Documentation Differences

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© 2018 Brandwood Biomedical www.brandwoodbiomedical.com© 2018 Brandwood Biomedical www.brandwoodbiomedical.com

Brandwood Biomedical has completed several MDSAP audits to date; We have developed a basic list of documentation for the MDSAP Audit:

Audit Documentation Requirements

MDSAP Process and Audit Task Required documentation

Management

Quality Manual

Quality Policy

Quality Objectives

Organisational charts

Policy / procedure on outsourcing

List of suppliers

Procedures for the control of documents and records

Management review procedures and associated record templates

Records of at least one completed management review

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MDSAP Process and Audit Task Required documentation

Device Marketing Authorization and Facility Registration

Submission

Marketing Clearance / Approval

Change Notification QMS / Products

Measurement, Analysis and Improvement

Procedure for Control of NC Product

Procedure for Investigations

Procedure for CAPA

Procedure for Data Analysis

Procedure for Complaints

Procedure for Recalls

Procedure and Templates for Internal Audits

Records for at least one completed internal audit

Audit Documentation Requirements (cont.)

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Audit Documentation Requirements (cont.)MDSAP Process and Audit Task Required documentation

Medical Device Adverse Events and Advisory Notices Reporting

Procedure for Adverse Events

Procedure for Advisory Notices

Design and Development

Procedure for the control of the design and development

Procedure for the control of design changes

Procedure for design transfer

Production and Service Controls

Procedures for planning of product realisation

Documented provisions for product cleanliness

Policies/procedures for validation/revalidation of processes

Procedures for statistical techniques

Procedures for control and calibration for measuring and monitoring devices

Procedures for validation of software systems

Procedures for the establishment of DHF/DMF

Procedures to ensure integrity and prevent accidental mixing

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Audit Documentation Requirements (cont.)MDSAP Process and Audit Task Required documentation

Production and Service Controls

Procedures for the establishment and completion of DMR

Procedures for device tracking where applicable

Procedures for handling customer property, as applicable

Procedures for acceptance activities

Procedures for establishing sampling plans

Procedures for rework (where applicable)

Procedures for preservation of products (components/parts)

Procedures for distribution controls (keeping of records)

Procedures for installation, if applicable

Procedures for servicing, if applicable

PurchasingProcedures for evaluation, selection and monitoring of suppliers

Procedures for acceptance activities

Template of supplier agreement

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Regulators included in the IMDRF will use the MDSAP audit (and its reports) to substitute for the evidence of manufacturer’s QMS certifications.

These countries will not require additional country-specific audits and may create more pathways for

product regulatory approvals in these target markets.

Benefits of MDSAP

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MDSAP audit, combined with a Canadian, Japanese or FDA

approval, can be used to obtain TGA registration

(ARTG Inclusion) of a Medical Device.

These are new pathways, in addition to current use of CE

Mark for Australian registration.

Benefits of MDSAP - Australia

TGA guidance: “Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices

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Benefits of MDSAP - Australia

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MDSAP Audit Certificates replace Brazilian GMP certificates.

ANVISA uses MDSAP certificates as evidence of conformity to RDA no 16/2013 requirements.

Benefits of MDSAP - Brazil

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MDSAP Audit Certificates replaceCMDCAS certificates.

Health Canada uses MDSAP certificates as evidence of conformity to Medical Devices Regulations sections 32(2)(f), 32(3)(j) and 32(4)(p).

Benefits of MDSAP - Canada

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© 2018 Brandwood Biomedical www.brandwoodbiomedical.com© 2018 Brandwood Biomedical www.brandwoodbiomedical.com

PMDA accepts MDSAP audit reports to reduce burden to medical device manufacturers.

PMDA may perform off-site inspection instead of on-site inspection or reduce documents for off-site inspection, when a MDSAP audit report is submitted.

Benefits of MDSAP - Japan

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Benefits of MDSAP - Japan

The Flow of PMDA QMS Inspection and MDSAP

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MDSAP audit reports are acceptable as a substitute for FDA routine inspections.

However, MDSAP audits will not substitute certain types of inspections, including:• For Cause

• Compliance Follow-up

• Pre-approval or post-approval

• Compliance with Electronic Product Radiation Control (EPRC) Regulations

Benefits of MDSAP - US

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Initial reviews of the MDSAP program and its implementation are overwhelmingly positive:

"MDSAP allows a reduction in the number of audits conducted resulting in less business

disruption. The MDSAP audit was well planned and the well-organized audit

expectations allowed us to plan resources ahead of time. Additionally, qualified and

competent auditing organizations conduct audits in a consistent manner.”

Initial Reviews

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IMDRF regulators have completed successful MDSAP

pilots

Wider adoption is imminent

Manufacturers who are ISO 13485:2016 certified are already a long way there

The increment from ISO 13485 is a manageable QMS update to be successful in MDSAP audits

MDSAP audits reduce/eliminate steps for

country-specific requirements in IMDRF jurisdictions

MDSAP audits reduce the regulatory burden to

medical device manufacturers

Conclusion

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…MDSAP truly opens a world of possibility for medical device manufacturers.

Conclusion

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Time for Q&A...

Think of something later? Ask us by [email protected]

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www.brandwoodbiomedical.com @arthurbrandwood https://www.linkedin.com/in/arthurbrandwood

https://www.linkedin.com/company/brandwood-biomedical/ You Tube Channel Brandwood Biomedical orhttps://brandwoodbiomedical.com/training-videos/


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