Introducing BSI BSI Medical Device Regulatory Update Galway, Ireland Dr. Michael Weissig EMEA Vice President Healthcare 26 June, 2015 Copyright 2014 BSI. All rights reserved.
Global Healthcare Mission To ensure patient safety while supporting timely access to medical device technology globally. Provide our customers thorough, responsive, predictable conformity assessments, evaluations and certifications that are recognized and accepted worldwide. 2
BSI Healthcare Profile Notified Body serving the Global Marketplace Hubs in London, Washington DC, Frankfurt, Hong Kong International market access Full product scope BSI Corporate HQ, London Globally operating teams of experts Orthopedic & Dental devices & Implants Vascular devices & Implants Active Implantable (AIMD) In Vitro Diagnostics Devices (IVDD) Active medical devices (electro-medical) General medical devices (wound care, Ophthalmic, surgical, drug-device combinations) Specialist Support expertise Software Clinical evaluation Animal Tissues Microbiology Biocompatibility Human Blood Derivatives 3
How Can BSI Support You and Your Clients in Global Expert Certification and Conformity Assessment? ISO 13485 Audit EU Conformity Assessment (CE) CMDCAS Audit Programme Japan MHLW JPAL Medical Audit Programme 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 with a Global Reach Conformity Assessment Malaysia (MMDD) Conformity Assessment SFDA Hong Kong Conformity Assessment 4
BSI Assessment, Certification & Services Services for Medical Device Manufacturers Registration and certification CE Marking, ISO 13485, ISO 14971, ISO 9001, ISO 14001 Clinical strategy and regulatory reviews Second and third-party auditing and verification Information and guidance via website, eupdates, and webinars Business improvement tools, performance benchmarking and software solutions Training Public training courses, In-house training course, e-learning courses 5
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 13485 MED01001ENGX Implementing ISO 13485 2 Day MED02001ENGX ISO 13485 Clause by Clause 2 Day MED41011ENGX How does my organisation understand / interpret... Essential Requirements by Region Performance Evaluations Clinical Evaluations MCE01001ENGX Animal Tissue MAT00101ENGX Internal Auditor ISO 13485 2 Day MED03001ENGX Lead Auditor ISO 13485 5 Day MED04001ENGX MED04101ENGX MED01801ENUS Global Requirements EU, Canada, US, Japan By Technology State of the Art Technical Standards Creating & Maintaining IVD Technical Files & Design Dossiers Creating & Maintaining Technical Files & Design Dossiers TFD00101ENGX CE Marking Devices with Software SMD41001ENGX 6
Serving a Global Marketplace BSI works with many of the largest medical device companies in the world including: 7
CE Marking: Speed-To-Market Programs CE-90 Standard Program 90 Working Days to CE Marking BSI Standard Service and Pricing Predictable Outcomes CE-45 FastTrack Reviews Completed in 45 Working Days Speed-to- Market Advantages Client Must Meet the Same High Standards of a Regular Review Premium Pricing Some Restrictions 8
Our Value Proposition 5 Core Reasons to Choose BSI Product Expertise our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies. Global Access we operate in over 100 countries with more than 100 years of experience with offices around the world. Speed-to-Market providing flexible solutions for manufacturers needing accelerated pathways to global markets. Confidence our rigorous review process combines speed with experience, integrity, independence and predictability. Partnership we focus on establishing a partnership with each client so we can work together to meet their goals. 9