The Third Annual BSI Medical Device Regulatory Road Shows

Transcription

1 The Third Annual BSI Medical Device Regulatory Road Shows September 2014 Monday, September 8, 2014 Santa Clara Biltmore Friday, September 12, 2014 Boston Marriott Burlington Wednesday, September 10, 2014 Radisson Newport Beach Monday, September 15, 2014 Minneapolis Marriott West Gary Slack Global SVP - Medical Device & Life Science Copyright 2012 BSI. All rights reserved. 15/09/2014

2 Audience Demographics Attendees in terms of Role: Regulatory Managers? Quality Managers? Regulatory Consultants? Who s Primary Focus is the MDD Who s Primary Focus is the IVDD Clients Who currently works with BSI? 2

3 Meeting Your Challenges as Key Regulatory Leads Within Your Organisation Product Lifecycle How does my organisation Maintain information sources such as Standards Regulatory requirements by region country Level How does my organisation understand / interpret... Essential Requirements by Region By Technology State of the Art Technical Standards How does my organisation ensure we are Compliant Manage Risk Test Compliance to increasing and evolving requirements Partner with an expert provider Post Initial Compliance How does my organisation Maintain compliance Monitor Compliance Close out non conformities Implement UDI Monitor Adverse Events (PMCF) Inc. Ess. Req. / Inc. Reg. Burden / Resource Stretch / Increased Need for Efficient & Reproducible Processes 3

4 An Ever Changing Regulatory Landscape Europe & Beyond Post PIP Audit Requirements Unannounced Visits Ever Increasing Emphasis on Clinical Evaluation Less Acceptance of Equivalence Data Based! Sea Change in the Requirements for Post Market Clinical Follow Up Relative Success of EU Regulatory Outsourcing is Driving Other Geographies to Review Their Existing Approaches Resource Constrained Governmental Agencies Looking to Third Party Provision e.g. Medical Device Single Audit Programme (US/Canada/Brazil and Australia) Japan Opening Class III Devices to Third Party Providers Increased Third Party Activity Within the Australian TGA Programme Catastrophic Fiscal and Reputational Cost of Adverse Events / Patient Injury and or Non-Compliance 4

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6 Staying Current & Maintaining Information Sources Subsidised Cost BSI Annual Reg. Update Road Shows BSI / White Papers Free Free BSI Regulatory Webinars Maintaining Information Sources Standards Regulatory Requirements by Region Country Level Free BSI e Updates Compliance Navigator 6

7 Introduction to CE Marking MDD1001ENGX Introduction to IVD Directive VMD01001ENGX Training and Maintaining Competence Free BSI Regulatory Webinars Risk Management MDR01001ENGX Post Market Surveillance MPM00101ENGX Medical Devices CE Marking 3 Day MDD41001ENGX IVD CE Marking 3 Day VMD41001ENGX Process Validation PVA00101ENGX Drug / Device Combinations MDD41801ENGX Understanding ISO MED01001ENGX Implementing ISO Day MED02001ENGX ISO Clause by Clause 2 Day MED41011ENGX How does my organisation understand / interpret... Essential Requirements by Region Performance Evaluations Clinical Evaluations MCE01001ENGX Animal Tissue MAT00101ENGX By Technology State of the Art Internal Auditor ISO Day MED03001ENGX Lead Auditor ISO Day MED04001ENGX MED04101ENGX MED01801ENUS Global Requirements EU, Canada, US, Japan Technical Standards Creating & Maintaining IVD Technical Files & Design Dossiers Creating & Maintaining Technical Files & Design Dossiers TFD00101ENGX CE Marking Devices with Software SMD41001ENGX 7

8 Expert Certification & Conformity Assessment CMDCAS Audit Programme Japan MHLW JPAL Medical Audit Programme ISO Audit Medical Device Single Audit Programme (MDSAP) INMETRO Brazil Product Certification How does my organisation ensure we are Compliant Manage Risk Test Compliance to increasing and evolving requirements Partner with an expert provider Conformity Assessment SFDA Conformity Assessment Malaysia (MMDD) EU Conformity Assessment (CE) Hong Kong Conformity Assessment Russian Conformity Assessment (GOST-R) 8

9 Monitoring & Maintaining Compliance Knowledge Mgmt Document Mgmt. Training Mgmt. Legislation Communication Assets Risk Mgmt Risks Analysis Methodologies Controls Compliance Mgmt CAPA Manager and Audits, Protocols, Checklists, Scorecards Action Manager Customer Portal and Org Structure, Create Findings, Add Users, Configure Reports/Dashboards Post Initial Compliance how does my organisation Maintain compliance Monitor Compliance Close out non conformities Implement UDI Monitor Adverse Events (PMCF) Performance Mgmt KPIs, Monitoring records Objectives & Targets Incident Mgmt Incidents Statistics Product Set of BSI Professional Services (Not BSI NB or Assurance) 9

10 BSI s is Focusing on Tools to Drive Enhanced Certification in order to Aid Robust, Efficient and Cost Effective Compliance Solutions to Enable or Maintain Market Access Product Lifecycle Compliance Navigator Maintaining Information Sources Standards Regulatory Requirements by Region Country Level How does my organisation understand / interpret... Essential Requirements by Region By Technology State of the Art Technical Standards How does my organisation ensure we are Compliant Manage Risk Test Compliance to increasing and evolving requirements Partner with an expert provider Post Initial Compliance how does my organisation Maintain compliance Monitor Compliance Close out non conformities Implement UDI Monitor Adverse Events (PMCF) Partnering to Succeed & Delivering Excellence 10

11 The Third Annual BSI Medical Device Regulatory Road Shows September 2014 Thank You Copyright 2012 BSI. All rights reserved. 15/09/2014