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  • 1. ARE YOU READY TO FACE THE GLOBAL MARKETPLACE? EXPERTISE • GLOBAL ACCESS • SPEED-TO-MARKET • CONFIDENCE • PARTNERSHIP ...making excellence a habit.
  • 2. BSI, HEALTHCARE LET BSI HELP YOU MEET THE WORLD WITH CONFIDENCE Verifying Regulatory and Quality Requirements for Medical Devices Around the World The challenges medical device manufacturers face in today’s highly competitive marketplace make it essential to ensure that your product meets all regulatory and quality requirements before launch. It is critical to work with a leader who understands the industry and has the experience to review and confirm the products’ readiness for market—efficiently, reliably and promptly. BSI is such a company that has been leading the way in assisting manufacturers to navigate through the maze of regulatory requirements. We are a respected, world-class Notified Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers—around the world. For more than 100 years, BSI’s expertise has provided an assurance of safety and quality to manufacturers in over 100 countries. The Best Route to Getting Your Products to Market As a client of BSI you will have confidence knowing that we conduct robust, comprehensive assessments that will stand up to scrutiny. We are well-known worldwide for fast, efficient and predictable service, meaning you will know what to expect with timely results and no surprises. This results in the best route to market. You will appreciate our unique combination of advanced technology and accessibility. Our experts make themselves available to clients throughout the process, which will inspire a sense of connectivity and partnership. Specializing in High-Risk Products BSI specializes in complex high-risk products requiring Design Dossier Reviews to include invasive, combination, implantable, animal tissue and novel medical devices. Five Core Reasons to Choose BSI, Healthcare When choosing BSI you can rely on our five core values: 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 and offices around the world to serve you. Speed-to-Market – providing flexible solutions for manufacturers needing accelerated pathways to global markets. Confidence – our stringent 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. Benefits of Working with an Industry Leader
  • 3. YOUR NOTIFIED BODY OF CHOICE • ISO 13485 QMS • CE Marking • Health Canada CMDCAS • Japan PAL • ISO 14971 Risk Mgt. Certification • FDA 510K Third-Party Reviews • FDA Accredited Persons Inspections • Australian EU CAB • Hong Kong CAB • China Product Regulation Service • Additional services available Speed-to-Market Programs • CE-90 Standard Reviews • CE-45 FastTrack Reviews • CE-Onsite FastTrack Reviews Additional Services • ISO 9001 QMS • Kitemark® Product Certification • Product Testing • Business Continuity • Occupational Health & Safety • Environmental Medical Devices Regulatory and Quality Special Services Medical Device eUpdate Service – Keep updated on what’s happening in the industry and changes in regulatory and quality requirements. You can take advantage of this free service by signing up at our website. Informational Webinars – We offer a wide variety of interactive multimedia presentations allowing convenient participation via a web-based interface. Medical Device Guidance Documents – Our online Guidance Documents provide assistance in understanding the requirements of the medical devices directives. Medical Device Training – BSI offers a comprehensive range of courses to address the needs of quality and regulatory professionals. Standards – BSI British Standards delivers leading-edge best practice solutions through the development and publication of more than 20,000 standards and related products.
  • 4. SPEED-TO-MARKET PROGRAMS Fastest and Most Experienced Route to Global Markets In the race to get new medical devices to market, speed is a crucial component. BSI has a strong commitment to providing the most experienced and fastest routes to global markets. This adds up to the kind of speed-to-market you need if you want to stay competitive, or more importantly, move ahead of the competition. Our Programs have been developed especially for medical devices needing Design Dossier Reviews. They combine speed-to-market with the integrity, independence, predictability and thoroughness that you have come to expect from BSI, Healthcare. Technology Driven BSI has the product expertise, knowledge and tools you need. We employ state-of- the-art technology that offers many e-solutions that enhance dossier submissions as well as the reviews. We continue to advance our systems to encourage transparency, speed and reliability. For customers who are prepared and ready-to-go!
  • 5. GETTING YOUR PRODUCT TO MARKET IS AS IMPORTANT TO US AS IT IS TO YOU Programs do not guarantee a CE Marking certificate in a certain amount of working days but commits to completing the review process with either a positive or negative recommendation. Programs exclude reviews outside BSI’s control (e.g., products containing medicines, animal or blood derivatives). CE-90 Standard Our clients enjoy working with us because we understand the challenges medical device manufacturers face in getting compliant products on the market quickly. We are continually developing Speed-to-Market Programs to meet the demands of the medical device industry–such as our CE-90 Program. The CE-90 is our standard Design Dossier service in which most reviews are completed within 90 working days from submission. We give you more predictability for better results. CE-45 FastTrack We make getting your product to global markets as important to us as it is to you. BSI knows every day can have an impact on the bottom line, so we created the CE-45 FastTrack Program. The CE-45 is an expedited Design Dossier service where most reviews are completed within 45 working days from submission. Our goal is to assist you in getting your products to market faster, realizing a faster return on your investment. CE-Onsite FastTrack CE-Onsite FastTrack Review Service is conducted at the customer’s premises, in which BSI Product Experts visit the facility for a dedicated period of time. This expedited service works toward a CE Marking target of 45 working days from submission. CE-Onsite Reviews usually allow for a much faster timeline with dynamic communications and opportunities for immediate response to questions. Real time for real results.
  • 6. REGULATORY AND QUALITY MANAGEMENT PROGRAMS AND SERVICES Product Certification Our comprehensive, one-stop shop approach offers you a wide range of proven regulatory and quality management programs and services that all work together to move your medical devices to international market promptly. These include: CE Marking CE Marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Directives and is a legal requirement to place a device on the market in the European Union. The three medical devices directives are: • Medical Devices Directive (MDD) • Active Implantable Medical Devices Directive (AIMDD) • In Vitro Diagnostics Directive (IVDD) FDA 510K Third-Party Review Program This is a program for manufacturers of lower risk (class II) devices who are required to prove substantial equivalence with a pre-cleared medical device on the U.S. market. BSI is an independent body accredited by the U.S. FDA to conduct 510(k) reviews under the third-party review program. Australia – EU CAB Importers of medical devices in Australia need to meet the requirements of the Therapeutic Goods Administration of Australia. BSI is designated as a Conformity Assessment Body under the Mutual Recognition Agreement (MRA) between EU and Australia. Pre-Clinical Trial Review Clinical investigations are expensive and time-consuming. Therefore manufacturers may want to have them reviewed by the Notified Body before they start. This is to help ensure that once they are completed, they are acceptable and sufficient to meet CE Marking requirements needed by the Notified Body. Japan PAL The revised Japan Pharmaceutical Affairs Law (PAL) expands regulation of medical devices sold in Japan. Quality Management System (QMS) requirements have been established incorporating ISO 13485:2003 and Global Harmonization Task Force (GHTF) principles. The 2005 revision allows BSI, as a Registered Certification Body (RCB), to certify lower risk Designated Controlled Medical Devices (Class II). China Product Regulation Service This service will assist clients globally to prepare and understand how to get their medical devices registered in China. It will include training on China’s requirements, coordinate testing, translation services, follow-up with China State Food Drug Administration, assisting in the product approval and license renewal procedures. Hong Kong Conformity Assessment Body (CAB) BSI was the first Hong Kong CAB under the Medical Device Administrative Control System. Using BSI as your HK CAB means BSI CE Marking clients need only to submit a minimal amount of technical documentation and companies can get the CE Marking and HK Registration with one assessment. As the need arises, additional services are continually added.
  • 7. Quality Management ISO 13485 Quality Management ISO 13485 is an international standard recognized for medical device QMS registration. It helps manufacturers consistently manufacture devices that are safe and fit for their intended purpose and meet regulatory requirements for manufacturing control. BSI is an accredited third party that conducts on-site assessments and makes recommendations. Health Canada CMDCAS BSI is an accredited Registrar by the Standards Council of Canada (SCC) to conduct ISO 13485 registration and is recognized under the Health Canada CMDCAS sector program. FDA Accredited Persons (AP) Inspection Programs BSI is an authorized Accredited Person (AP), recognized by the FDA to conduct medical device facility inspections as an alternative to the traditional inspection by an FDA official. As an AP, we are allowed to assess the quality systems of eligible manufacturers. Pre-Assessment Service An opportunity for a company to have an informal preliminary assessment that will not affect the outcome of the registration. This service will identify major flaws or gaps in the systems that the manufacturer can then correct. Risk Management Certification ISO 14971 is the international standard recognized as the model to meet expectations for risk management. A risk management system that meets ISO 14971 ensures that risks are addressed throughout the product life cycle. BSI ISO 14971 Certification provides independent confirmation that the manufacturer’s risk management system meets the international ‘state of the art’. Additional Services BSI is a leading global independent business services organization that inspires confidence and delivers assurance to customers with standards-based solutions. Some of our additional services include: Quality Management System A Quality Management System (QMS) gives you the framework to monitor and improve performance. ISO 9001 is the world’s most established quality framework and sets the standard not only for quality management systems, but management systems in general. Kitemark® The Kitemark,® which is highly recognized in the United Kingdom, is a product and service certification mark, and is a symbol of trust, integrity and quality. Product Testing We offer worldwide Product Testing capabilities through our UK testing facilities. Business Continuity Management BS 25999 is the world’s first British standard for business continuity management and was developed to assist companies to continue operations in the event of disruptions. Occupational Health & Safety Management An Occupational Health and Safety Management System promotes a safe and healthy working environment. Environmental Management An Environmental Management System provides a framework for managing environmental responsibilities efficiently. Please visit our website for additional services.
  • 8. EXPERIENCE YOU CAN COUNT ON The benefits of having professional, experienced and well-qualified Product Experts cannot be overstated when it comes to meeting customer needs to handle the ever-changing, complex medical device industry. BSI’s Product Team has a combination of regulatory as well as industry expertise to meet these challenges. Product Experts Strong, robust technical documentation is the heart of the manufacturer’s claim of compliance and thorough review by product experts provides the manufacturer confidence for signing defendable declarations of conformity. At BSI we use Product Experts to conduct the Technical visits. Our highly trained Product Experts have the knowledge, background and skill to handle Technical documentation evaluations, which are substantially different than Quality Management audits. Changes in the Medical Device Directives (MDD) raise the importance of sampling technical documentation, which is something BSI has already been conducting for years. BSI, Healthcare vigilantly monitors the changes in the industry and helps raise awareness and assess manufacturer readiness. Project Management Team A Project Management Team is assigned, based on the need, to handle each customer’s account. The team’s responsibility is to manage the account, organize the necessary steps, oversee the proper flow of all documentation and coordinate the scheduling. The Healthcare Team may include a Team Leader, Project Manager, Product Expert, Client Manager or Auditor, and Microbiologist, along with the Sales Representative and Client Services Coordinator. Microbiologists BSI requires the use of trained Microbiologists because sterility is critically important to many medical devices and anything less than complete confidence in a manufacturer’s level of sterilization control could place patient safety in significant jeopardy. As a key step in the manufacturing process, sterilization must be closely reviewed. Whether products are sold as sterile or ultimately consumed as sterile, the sterility process requires 100% confidence as the ramifications of failure in this area are enormous. Many manufacturers, after experiencing a BSI Microbiologist assessment, have reported implementing positive changes from the feedback they received. Product Experts EXPERTISE AND SPECIALTIES
  • 9. Quality Assessors BSI Client Managers, who are our Assessors possess experience in the medical device industry, which gives them a greater understanding of the customers’ challenges. They have empathy with our clients as they know what it means to be on the other side of an assessment and to submit a quality system to scrutiny. In addition, BSI Client Managers have undergone extensive training programs and maintain strong credentials in their fields of expertise. BSI also has a unique matching system that matches the manufacturer’s product type to the appropriate auditor’s credentials and background. BSI is known for its fair but thorough audits. Product Specialties BSI specializes in multifaceted, high-risk medical devices requiring Design Dossier Reviews. BSI’s core competency and our advanced level of skill are perfectly matched to handle the complexities of these types of medical devices which include: • Vascular • Orthopedic • Active Implantable • Electro-Medical • Sterilization Validation • Human Blood and Animal Tissue • Novel Technologies • Invasive and Surgical • Wound Care • Dental • Combination/Medicinal Substances • Ocular
  • 10. TRAINING IN THE RIGHT DIRECTION Implementing ISO 13485:2003 This course introduces the concepts needed to understand, develop and implement a quality management system as outlined in the medical devices standard ISO 13485:2003. ISO 13485:2003 Internal Quality Systems Auditor The Internal Auditor course provides the knowledge and skills required to conduct ISO 13485:2003 Quality Management Systems Internal Audits. Through small group activities, audit role plays, lively discussions and instructor-led lectures, students gain a thorough understanding of the principles of auditing. This course is RABQSA accredited. On-site Training Whether you are training groups of six or 600, BSI On- site Training is a cost-effective option. BSI offers training on dozens of topics, from auditing to ISO 9001:2008 to Six Sigma. All of our training can be customized to match your specific requirements. ISO 9001:2008 Lead Auditor with Emphasis on ISO 13485 This course begins with a review of ISO 13485:2003 and continues to teach the principles of process. Students successfully completing this course by passing the exam fulfill the RABQSA training requirements for QMS Auditor and QMS Lead Auditor certification. Additional Subjects: • ISO 13485:2003 Quality System Regulations • Medical Devices CE Marking • Overview of Medical Devices Design Controls • Japan PAL • Canadian Medical Devices Regulations • ISO 14971:2007 Risk Management Webinars and e-learning Taking courses on the Web saves money on travel and provides the flexibility to fit the training into your busy life. PUBLIC • ONSITE • e-LEARNING • WEBINARS Medical Device Training Medical Devices for use in the global healthcare markets face a range of demanding regulatory approval requirements and standards. BSI has world-class experts who specialize in training individuals and organizations to meet these standards. We offer a comprehensive range of Medical Device courses including Public, Onsite, e-Learning and Webinar Courses. Visit our website for more information at http://www.bsiamerica.com/MDtraining
  • 11. Contact us 1 800 862 4977 email: healthcare@bsigroup.com www.bsiamerica.com Let us put our team behind yours. ...making excellence a habit.
  • 12. BSI, Healthcare 12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902 USA Tel: 1 800 862 4977 Fax: 1 703 437 9001 email: healthcare@bsigroup.com www.bsiamerica.com BSI – Canada 6205 Airport Road, Suite 102 Mississauga, ON L4V 1E1Canada Tel: 1 800 862 6752 Fax: 1 416 620 9911 email: inquiry.canada@bsigroup.com www.bsigroup.ca BSI – Brazil Avenida Eng Luis Berrini N.º 1400 – 1º Andar – CEP: 04571-000 Brookline, Sao Paulo SP Brasil Tel: +55 13 3223 5770 Fax: +55 13 3223 3851 email: informacao.msamericas@bsigroup.com www.bsibrasil.com.br BSI – Mexico Torre Mayor Av. Paseo de la Reforma No. 505 Piso 41 – Suite C – Col. Cuauhtémoc, C.P. 06500 México, D.F. México Tel: +52 55 5241 1370 Fax: +52 55 5241 1374 email: informacion.msmexico@bsigroup.com www.bsigroup.com.mx BSI – United Kingdom Kitemark House Maylands Avenue Hemel Hempstead HP2 4SQ United Kingdom Tel: +44 (0)8450 765600 Fax: +44 (0)8450 765601 email: ps.healthcare@bsigroup.com www.bsi-global.com BSI JAPAN K.K. – Japan Toranomon Kotohira Tower 21F 1-2-8 Toranomon Minato-ku Tokyo 105-0001 Japan Tel: +81 3 5501 7121 Fax: +81 3-5501-7127/7128 email: japan.info@bsigroup.com www.bsi-japan.com BSI China – Shanghai 23/F Evergo Tower 1325 Huaihai Middle Road Shanghai 200031 China Tel: +86 21 6431 2638 Fax: +86 21 6474 0635 email: sh@bsigroup.com www.bsigroup.cn BSI Group: Standards • Information • Training • Inspection • Testing • Assessment • Certification Copyright © 2009 The British Standards Institution All Rights Reserved BSI/USA/149/MS/0808/E The BSI certification mark can be used on your stationery, literature and vehicles when you have successfully achieved certification. BSI – Hong Kong 19/F AIA Plaza 18 Hysan Avenue Causeway Bay Hong Kong Tel: +852 3149 3300 Fax: +852 2743 8727 email: hk@bsigroup.com www.bsigroup.hk India – New Delhi BSI India Private Ltd The MIRA Corporate Suites Plot 1&2 Ishwar Nagar Mathura Road New Delhi 110065 India Tel : +91 11 2692 9000 Fax: +91 11 2692 9001 email: bsi.delhi@bsigroup.com www.bsigroup.co.in BSI – Singapore 460 Alexandra Road #08-01/02 PSA Building Singapore 119963 Tel: +65 62700777 Fax: +65 62702777 email: sgp@bsigroup.com www.bsigroup.sg