MDSAP - FDAnews

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MDSAPMedical Device Single Audit Program

MDSAP Overview Benefits Challenges Lessons learned.

MDSAP- Positives One audit for all regulators involved Thorough audit of QMS. Predictability of audit-MDSAP checklist and MDSAPcompanion document can be used to prepare for audit. Qualitative grading system (1-5)- removes subjectivity. Basedon direct/ indirect impact to device safety and performance.

MDSAP- Challenges Faster paced audit, stayed on track to schedule- each chapter ofcompanion document must be completed within allocated time. Depending on the audit result - Unannounced audit within 6months, by potentially all regulators. More audit days- # of activities & region(s) product sold into (not# of personnel). Multiple audit streams ( AO trainees) & site tours. Extensive documentation requests- 300 day.

Lessons learned Speed of execution essential- objective evidence readily availableto meet allocated times. Pre- stage SME’s- ready! Key focus areas;-Training- job descriptions, resumes, effectiveness-Quality plans for implementing quality objectives-Mock MDSAP audits/ gap assessments-Off site documentation storage-System demonstrations/ software validations.

Thank you

MDSAP:AN AO PERSPECTIVEPresented by: Alexander CrosbyAmericas Medical Program Manager,Intertek Business AssuranceIntertek Business Assurance

COMMON MISUNDERSTANDINGS (1) Not all products distributed in each jurisdiction need to be cover in scope of MDSAPcertificate Regulatory requirements do not need to be addressed by documented processes. This is a FDA-centric program The is a Health Canada-centric program and the application of a CMDCAS mentality toMDSAP Only applicable to higher risk class devices (i.e. Class 2 and above in Canada) Design is out of scope for lower risk device Australian Sponsor and/or Brazilian Importer and/or Japanese MAH are responsible formeeting all requirements not the manufacturer. European EC Certificate is all that is necessary to meet Australian Requirements MDD essential requirement are the same as to Australian essential principles

COMMON MISUNDERSTANDINGS (2) Audit plans can be revised andprocesses can be moved around toaccommodate on-site issue. We can provide an definitive threeyear forecast of audit timing Sampling selection & audit &product coverage same as prioraudits (auditor discretion.) Which locations are within scope The purpose, use and “value” ofaccredited certificates vs. MDSAP RArecognized certificates

MANUFACTURERS’ CHALLENGES Underestimating level of effort and cost required for adequate preparation, in particular, address ofregulatory requirements in the management system. Be realistic about market expectations (i.e. When you expect launch products in new marketsallowed by MDSAP, link product specific timelines to intent to market in each jurisdictionselected) Unrealistic expectations of time to address areas of concern from stage 1 Inadequate detail in processes to address additional / new regulatory requirement (i.e. Treat alljurisdictions equally with specification of detail.) Not adequately addressing prior findings, thus getting repeat findings in your first MDSAP audit withimpact on severity grading. Increased audit time often results in identification of non-conformities that were not encountered Absence of documented agreement with Australian sponsor and/or Brazilian importer and/orJapanese MAH Producing detailed relevant, timely, detailed information from virtual manufacturers in the languageof the audit.10

PREPARING FOR MDSAP (1)Be prepared to expertly demonstrate that youhave satisfied all regulatory requirementsapplicable to your devices, including: Regulatory roles per jurisdiction Device classification Market clearance Change notification Reporting device adverse event and fieldcorrective action/recalls

PREPARING FOR MDSAP (2) Understand the scope and context forthe upcoming MDSAP audit If shipping medical devices to a MDSAPjurisdiction, country-specific requirementswill apply For multi-site operations, the sites thatconduct activities for another site will beassessed per the requirements for theMDSAP cert Intra-company support activities aresubject to review of contracts, etc. toverify coverage of audit requirements Use the QMS built into the QMS –internal audits, CAPA, managementreview, quality plans, etc.

TOTAL QUALITY. ASSURED.Total Quality Assuranceend-to-end on a global scaleGlobal market leader in Assurance3000 Auditors, 100,000 Audits annuallyGlobal market leader in Testing, Inspection and Certification1,000 sites, 100 countriesInnovative and bespoke quality solutionsfor our clients, 24/7Constantly evolving our servicesto help customers manage increasingly complex risksFTSE 100 companyin the support services sectorMarket capitalizationover 6 billion13 Intertek Group13

WE ARE UNIQUELY POSITIONED TO DELIVER ATIC SOLUTIONS WITH OURGLOBAL NETWORK43,000 100 employeescountriesGlobal MarketLeader inAssuranceGlobal MarketLeader in TIC3,0001,000 auditorslabs and offices100,000 80 audits/yrlanguagesAssurance Testing Inspection CertificationSystemic approach to Qualityand Safety with ATIC Solutions14

CONTACT INFORMATIONAlex Crosby 1 (434) 242-4341alexander.crosby@intertek.comGeneral Inquiries 1 (800) m/auditing/medical

-Training- job descriptions, resumes, effectiveness -Quality plans for implementing quality objectives -Mock MDSAP audits/ gap assessments -Off site documentat

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The MDSAP: Easing the Audit Path for Quality Management Systems MDSAP Auditing Specifics and Considerations As noted earlier in this paper, the MDSAP audit has been designed to meet the requirements of ISO 13485. The audit specifically addresses five primary processes, including: 1) management; 2) measurement, analysis and

But: registrars auditing to MDSAP already have 13485 and MDD baked into the current audit process!!! . Scope was MDSAP, ISO 13485(surveillance) and Medical . The updates

MDSAP Audit 23 Audit duration is based on the elements to be covered in the audit (up to 94), not on number of employees (as in ISO 13485) A pre-determined amount of time is allocated to each task (range: 15 -44 minutes) reduced for no sterilization, service, installation or implants (¾ hr. each), or design (5 hrs)

Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observer to the MDSAP Regulatory Authority Council (RAC) and Subject Matter Expert (SME) Work Group. 4. When is it anticipated that the MDSAP will go live?

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