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Presentation of Intertek Systems Certification and Notified Body Services Mary P Ryan Director Intertek AMTAC Certifica

Presentation of Intertek Systems Certification and Notified Body Services Mary P Ryan Director Intertek AMTAC Certification Services Ltd December 2009. Agenda. Brief Introduction to Intertek Intertek’s Medical Capabilities Medical Organisation Why choose to work with Intertek Amtac S.C?.

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Presentation of Intertek Systems Certification and Notified Body Services Mary P Ryan Director Intertek AMTAC Certifica

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  1. Presentation of Intertek Systems Certification and Notified Body Services Mary P RyanDirector Intertek AMTAC Certification Services LtdDecember 2009

  2. Agenda Brief Introduction to Intertek Intertek’s Medical Capabilities Medical Organisation Why choose to work with Intertek Amtac S.C?

  3. Intertek Overview 2009

  4. Our Heritage 1885 Caleb Brett founds a marine surveying business today Now recognised as the famous“ETL” mark 1896 Thomas Edison establishes what’s later renamed as the Electrical Testing Laboratories (ETL)

  5. An Extensive Global Network FTSE 100 company in the Support Services sector Market capitalisation at £1.5 billion More than1,000laboratories and offices Over24,000employees More than110countries

  6. Our Mission Commitment To add value for our customers Innovation Provide solutions to support customer success Expertise Industry specific knowledge and competitive know-how across diverse markets Confidence For customers to succeed in the global marketplace

  7. Our Industries Supporting our customers in their global trade Our organisation What we do Our organisation The industries we operate in What we do The industries we operate in Consumer Goods Commercial & Electrical Oil, Chemical & Agri Analytical Services Industrial Services Minerals Aerospace & Automotive Building Products Chemical Consumer Goods & Retailers Electrical & Electronic Energy Food & Agriculture Government & Institutions IT & Telecom Industrial Medical & Pharmaceutical Petroleum Toys, Games & Hardlines Textile, Apparel & Footwear Testing Inspection Certification Auditing Outsourcing Advisory Quality Assurance

  8. Amtac – Certification & Notified Body What does this mean? Intertek ‘Amtac Certification Services Ltd’ (ACSL) is a highly recognised Certification Service and Notified Body. Amtac was the first Notified Body in the UK and participated in the training & development for all other major Notified Bodies under the MHRA. Amtac Certification was acquired by Intertek Group in 2003, but remains as a legal entity. As a Certification and Notified Body service, Intertek ‘Amtac’ is an organisation which the National Authority (Competent Authority) of a member state designates to carry out conformity assessments described in the annexes of the medical device directives. The Medicines and Healthcare Products Regulatory Agency ‘MHRA’ is the UK competent authority. Intertek ‘Amtac’ is qualified to perform all Medical Device Annexes and functions for which it is designated. Amtac has full scope for medical devices. Intertek ‘Amtac’ is accredited under UKAS, MHRA & Swedac through conforming to ISO 17021 to perform Certification Activities for MDD 93/42/EEC CE-Marking (incl Own Brand Labelling), ISO 9001, ISO 14001, OHSAS 18001, ISO 14971, ISO 13485, CSR among others.

  9. Medical capabilities

  10. Our Medical Expertise Complete service offering within the medical device & healthcare sector. Full scope medical device capabilities (auditing, NB & CB certification, testing, training, consulting) Specialising in Medical Device, Drug Device Combinations, Healthcare Providers, Hospitals, Sterile Service Departments, Endoscopy Units. Employ leading Industry experts, best in class Currently plays a significant part in the provision of QMS 9001 / ISO 13485 & MDD 93/42/EEC to UK Healthcare providers. Global network of experts and auditors (APAC, EMEA, Americas) Major market share; 13% of the global industry for medical certification of ISO 13485. In the frontline of the medical certification industry through our Centre of Excellence

  11. Medical Program Management • Advisory services: • Clinical studies • Regulatory affairs • Training • Performance test • Materials testing & evaluation • Testing: • -IEC 60 601-1 series • -IEC 61010-1 series • EMC • Bluetooth • R&TTE • ETL • CB • ...and many more • Inspection: • 510(k) • FDA AP • ISO 14971 • IEC 62304 • RoHS • WEEE • Systems Certification: • -MDD (93/42/EEC) • ISO 13485 / 9001 • ISO 14001 / 18001 • Canadian CMDCAS • Japanese PAL • Taiwan TCP • Australia MRA • ...and many more Intertek Medical Program Management Client Market access EU, Canada, Taiwan, Japan, US, Australia 11

  12. Intertek Certification – A Global Presence This is how Intertek Systems Certification business is set up Globally. Sweden UK Ontario Germany Shanghai Korea Quebec Japan Massachusetts Shenzhen Dubai Mexico City Vietnam Thailand Columbia Bangalore Chennai Mumbai New Delhi Buenos Aires SC Medical Excellence Centres

  13. Sample Integrated Management Systems Mayborn wanted to consider wider accreditations/certifications, here’s an example of integrated system audits we perform…. ISO 9001 MDD Full Scope/DAMAS ISO 13485 / CMDCAS TCP / PAL / CSR ISO 14001 • Integration benefits • Policy and goals • Process control • Competence, training and job descriptions • Document control • Improvement process • Follow up on system performance • Internal audits OHSAS 18001 13

  14. Why choose to work with Intertek Amtac S.C? Decades of Technical Experience ; 1st Notified Body in UK & one of the first in EC. Travelling to 34 countries our Auditors / Technical experts can advise on best practise Sits on various EU working groups for updates on various relative regulations, directives and guidance. 14 years in Israel One of the largest Notified Bodies in Israel; > 80 clients. Working with all sizes of organisations; incubator, set up, established and international. Intertek have invested in local Israeli Auditing resources (wide scope) Intertek have invested in a Dedicated Regional Client Manager; Hebrew speaking first point of contact for all Clients. Modular approach to Technical Files and Design Dossiers; aiding clients to get it ‘right first time’ and to accommodate up to date changes to legislation/directives. This approach can also support budgetary requirements. Access to complimentary medical device / pharma services e.g. High-End Analytical Services (ex ICI), Electrical NB services; EMC, Safety and Performance Testing, High-End Materials Science Group for preventative and material failure analysis. (ex ICI)

  15. Why choose to work with Intertek Amtac S.C? Medical Global Centre of Excellence: UK, Sweden, North America, China Integrated Audit program; 9001, 13485, 14971, MDD, 14001, 18001, Japanese PAL, Taiwanese TCP, Canadian CMDR (CMDCAS), CE. Full scope Medical Device Directive Service Offering; leading world experts; Value Add! Desk top services for Own Brand Labelling for MDD & IVDD (average turn-around = 20 days Turn-around-times for TF / DD’s is average 30 days from submission. Competitors advertise 90 working days with premium services at 45 working days. TF / DD’s should be scheduled with Administrator in order to satisfy TAT’s. Intertek can facilitate 2nd party audits for clients sub-contractors or suppliers on a global platform; all audits conducted in local language and reported in both local and english language. No Hidden costs & price competitive Local Active Sales Agent Shizim LSA for all business enquiries.

  16. Intertek local medical office: Intertek ‘AMTAC Certification Services Ltd’. Contact: Mary P Ryan, Director, UK Operations Manager Contact: Anand Karandikar, UK Sales Manager Davy Avenue, Milton Keynes, Bucks, MK58NL. Tel: 01908 85 7724 Intertek local representative office in Israel: LSA – Life Science Accelerator Ltd Contact: Yuval Almougy Contact: Miri Aharonson Tel: +972-3-900-2000 yuval@shizim.com ; miriah@shizim.com Local Intertek Medical Office

  17. Client Responsiveness - Testimonials Intertek is built upon a strong ethos of customer service – an admired company “ This is exactly the type of support we envisaged from the outsource agreement and I’m pleased to say that Intertek fully delivered.” “ Intertek’s mission statement of proving innovative solutions to global companies is exemplified in the services it provides Agfa Healthcare…. Intertek offers leading edge consultancy and testing services both remotely, on-site and in requested countries to allow Agfa to focus on their core business……” “ (Intertek) RAM has provided us with leading-edge knowledge and processes to assess the safety of our products as we design them, giving us confidence that we will ask the right questions and find the right solutions to any problem.”

  18. We are behind many successful organizations...

  19. Strong Globally. Strong Locally.

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