AN OVERVIEW OF UL Life & Health Your goals are our challenge

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1 AN OVERVIEW OF UL Life & Health Your goals are our challenge Ваши цели наша задача May UL LLC

2 Agenda UL`s reputation UL Life&Health Medical Device Testing & Regulatory Services The only source of knowledge is experience Albert Einstein 2

3 WE ARE A GLOBAL FORCE FOR GOOD At UL, our mission of working for a safer world since 1894 is at the core of everything we do. - Advancing safety through careful research and investigation - Preventing or reducing loss of life and property - Promoting safe living and working environments for all people 3

- Advancing safety through careful research and investigation - Preventing

4 DELIVERING UNMATCHED EXPERTISE & THOUGHT LEADERSHIP From the adoption of electricity to the advent of wireless interoperability, UL is the leading voice for global safety. Our deep knowledge and expertise make us invaluable in: - Developing standards - Creating codes - Researching safety breakthroughs - Helping customers design, produce, package and sell safer products 4

Our deep knowledge and expertise make us invaluable in: - Developing standards - Creating

5 WE PROVIDE GLOBAL MARKET ACCEPTANCE Our Marks are on nearly 22 billion products worldwide, per year, signaling peace of mind to consumers, customers, businesses and governments. 5

6 Leveraging UL s expertise to support regulatory acceptance for the critical systems essential to our health and well being FOCUS: Food safety Water systems Medical devices 6

7 LIFE & HEALTH INDUSTRIES OF FOCUS - Water Systems - Water Quality - Plumbing - Medical Devices - In-Vitro Diagnostic Devices - Hospital and Lab Equipment - Personal Health and Hygiene CERTIFICATION - Safety Certification - Pre-certification Review - Third-Party Regulatory Approvals - Health Effects Certification - Sanitation Certification - Multiple Listing and Private Labeling - Data Acceptance Program VALIDATION - Process Validation TESTING - Non-clinical Testing - Interoperability Testing - Analytical Testing - Usability Testing - Performance Testing AUDITING - Clinical Services Audit - Management Systems Assessment Audit - Risk Identification and Management Audit ADVISORY AND EDUCATION - Food Safety Advisory Services - Regulatory Advisory Services - Human Factors Engineering Advisory Services - Clinical Research Organization Advisory Services INSPECTION - Field Inspection Services - Follow-up Services - Field Evaluation 7

Program VALIDATION - Process Validation TESTING - Non-clinical Testing - Interoperability Testing - Analytical Testing - Usability Testing - Performance Testing AUDITING - Clinical Services Audit -

8 Global Market Access Solutions for the Health Sciences Industries Clinical Research Organization Services Medical writing Project management Monitoring & quality assurance in accordance with EN ISO Biocompatibility,Sterilization,Microbiology,Virological Testing Physical-Chemical Characterization,Mechanical Testing Packaging and Transport Testing including Shelf life studies Testing of ophtalmic devices 8

14155-1 Biocompatibility,Sterilization,Microbiology,Virological Testing Physical-Chemical

9 What is UL s Health Sciences Industry? We re more than U.S. Safety Testers Global Third Party Services Regulatory Accreditations Industry Advocate Leaders in the Health Sciences Industries First ISO Registration More 510(k) Third Party Reviews than any other Accredited Person Innovative Approach Early Engagement Notified Body under MDD and IVDD # 1 Issuer of CB Certificates for MED Multiple CBTL locations to serve you

Safety Testers Global Third Party Services Regulatory Accreditations Industry Advocate Leaders in the

10 Global Market Access Solutions for the Health Sciences Industries Access to Global Markets Regulatory Services Product Registration: - US-FDA 510K, EU-CE Marking (MDD/IVDD), China-CFDA, Brazil - INMETRO Mark, Japanese PAL 3 rd Party Certification Quality System Registration - ISO under CMDCAS Testing, Evaluation and Certification Product Safety Testing and Certification to IEC/UL 60601, IEC/UL Quality System Certification (ISO 13485), Knowledge Solutions Risk Management (ISO 14971) Full live cycle human factor engineering service (usability)

- ISO 13485 under CMDCAS Testing, Evaluation and Certification Product Safety Testing and Certification to IEC/UL 60601, IEC/UL 61010

11 Global Market Access Solutions for the Health Sciences Industries Software certification for global regulatory technical file submissions Audits to software process system standard IEC Software certification according to IEC ,3rd. Edition and ,2rd.Edition 11

submissions Audits to software process system standard IEC 62304

12 Global Market Access Solutions for the Health Sciences Industries UL can actively support the Russian manufacturer according the goverment modernisation program in testing and validation of data for home health equipment in combination with IT Technology Home health care equipment testing and evaluation according IEC A clearer path to compliance Interoperability; data integrity,maintenance schedule requirements; infrastructure and power-back availability, education and training for patients needs to be adressed UL can offer a full program of tests including training and education 12

testing and evaluation according IEC 60601-1-11 A clearer path to compliance Interoperability; data integrity,maintenance schedule requirements;

13 Global Market Access Solutions for the Health Sciences Industries UL s ehealth Services Wireless Benefit from a complete range of testing and advisory services for Medical Devices Pre-compliance Advisory Services Interoperability Regulatory Bluetooth Qualification Testing 13

and advisory services for Medical Devices Pre-compliance Advisory

14 Where UL Is Global Capacity

15 Global Market Access Solutions for the Health Sciences Industries Education services E Learning provided by UL University Webconferences Public and Private Seminars Webinars For more information or if you have questions Medical.Inquiry@ul.com or visit ul.com/medical You would like have a contact in your own Russian language Marion Behse Marion.Behse@ul.com 15

more information or if you have questions email Medical.Inquiry@ul.com or visit ul.

16 Thank you.спасибо The important thing is to never stop questioning Albert Einstein May UL LLC

Welcome to UL Protecting People, Products and Places

Welcome to UL Protecting People, Products and Places A symbol 22 billion ul marks appear on 69,795 manufacturers produced ul certified * 23,612 certified for energy star* of trust Facts & Figures 2014