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Medical BSI Experience
Medical BSI Experience
Medical BSI Experience
Medical BSI Experience
Medical BSI Experience
Medical BSI Experience
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Medical BSI Experience

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  • 1. Active Medical Devices Flexible, Fastrack solutions from BSI BSI: Expertise and experience Supporting life
  • 2. Unrivalled expertise from the leading Active Devices Notified Body BSI Healthcare is justifiably proud of its status in the industry as an Active Devices Notified Body. Nowhere is this more clearly seen than in our level of experience and expertise, our large specialist Active Devices team has 12 technical experts. 11 Graduate degrees held by the team Over 200 years of experience in... EN 60601 family of standards Infant Warmers & Incubators X-rays Body worn sensors Surgical Lasers Opthalmic Surgery Hearing Aids RF & Cryosurgery Ultrasonic Devices Patient Monitors Telemetry Gamma Cameras & Detectors Anaesthesia Delivery Systems Patient Ventilators Heart Lung Machines Haemodialysis Software Design Team Expertise Medical Technology Regulatory Affairs Electronics and Communication Engineering Systems Computer Science and Radip Communication Clinical Engineering Micro Electronics System Design Mechanical and Medical Device Engineering Electrical & Electronic Engineering Bio Physics Medical Physics Physics Graduate Degrees
  • 3. Getting your product to market is as important to us as it is to you Step 1: BSI Prepares A Quotation BSI company representative meets with your organization to discuss your requirements and the available solutions. BSI has a full portfolio of global solutions and will provide the best recommendation for your requirements. Step 2: BSI Performs A Conformity Assessment A dedicated BSI Project Manager will be assigned to your company, supporting you throughout the process. Quality Management System audit is performed. Technical files reviewed by experienced experts within agreed timescales thereby providing predictability. Step 3: Certification Decision Successful Assessment leads to a Project Manager recommendation for certification. Certification Decision Team will review the recommendation file and if satisfactory approve certification. Step 4: Certificate Issue Upon successful certification a certificate will be issued to your company within days. Step 5: Certification Maintenance On –going surveillance audits and reviews monitor for continued compliance. Your BSI Project Manager is available to support you when you have questions.
  • 4. Accelerate your product launch with our speed-to-market programmes 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. CE-Onsite FastTrack BSI CE-Onsite FastTrack Review Service is aimed at medical device manufacturers needing to get their products to European markets quickly and safely. The review service is conducted at the customer’s premises, in which BSI product experts visit the facility for a dedicated period of time. CE-Dedicated FastTrack This premium CE marking programme is for high risk medical devices requiring design dossier reviews. CE-45 FastTrack BSI knows every day can have an impact on the bottom line, so we created the CE-45 FastTrack programme. CE-90 Standard The CE-90 is our standard Design Dossier service in which most reviews are completed within 90 working days from submission. Please note: Our programmes do not guarantee a CE marking certificate will be issued within a certain amount of working days, but are based on completing the review process with either a positive or negative recommendation. FastTrack and CE-90 are not available for devices utilising animal tissue or containing human blood derivatives or medicinal substances. 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 also provide expert insight into emerging requirements and regulations. We offer a comprehensive range of Medical Device courses in an array of formats, including Public, On-site, e-Learning and Webinar Courses. Visit www.bsigroup.com/training for our full range of courses. FDA 510K Third Party Review This programme is 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 U.S. FDA to conduct 510(k) reviews under the third party review programme.
  • 5. Five core reasons to choose BSI When choosing us as your Notified Body, you can rely on: Speed to market We provide flexible solutions for manufacturers needing accelerated pathways into the marketplace. Confidence Our stringent robust 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 your goals. 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.
  • 6. Your partner in worldwide compliance: Call BSI today on +44 (0)845 080 9000 or visit www.bsigroup.com/healthcare – to start your partnership Global expertise Certification services ISO 13485 QMS auditing CE marking Health Canada CMDCAS Japan PAL FDA 510k Third-Party Review Programme FDA Accredited Persons Inspections Australia EU CAB Hong Kong CAB Russian Registration Certification Taiwan TCP Training courses CE marking and the Medical Device Directives 13485 Auditing Clinical Data Requirements, PMS and Vigilance Device Drug Combinations Environmental Risk Management Software German Medical Device Regulation IVD/Technical File BSI/1597/0512/BLD BSI - Germany Eastgate Hanauer Landstrasse 115 60314 Frankfurt Germany T:7 +49 (0)69 222289 200 F:7 +49 (0)69 222289 300 E:7 de.medicaldevices@bsigroup.com www.bsigroup.de BSI - Netherlands Adam Smith Building T.R.Malthustraat 3c Amsterdam 1066 JR The Netherlands T:7 +31 (0)20 346 0780 F:7 +31 (0)20 346 0781 E:7 info.nl@bsigroup.com www.bsigroup.nl BSI - EMEA Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP United Kingdom T:7 +44 (0)845 080 9000 F:7 +44 (0)1908 814920 E:7 eu.healthcare@bsigroup.com www.bsigroup.com BSI Group America Inc. 12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902 USA T: 1 800 862 4977/703 437 9000 F: 1 703 437 9001 E: healthcare@bsigroup.com www.bsiamerica.com BSI Group Canada Inc. 6205 Airport Road, Suite 102 Mississauga, ON L4V 1E1, Canada T: 1 800 862 6752 F: 1 416 620 9911 E: inquiry.canada@bsigroup.com www.bsigroup.ca/en-ca www.bsigroup.ca/fr-ca BSI Group Mexico, S. de R.L. de CV. Torre Mayor, Av. Paseo de la Reforma No. 505, Piso 41 – Suite C Col. Cuauhtemoc, C.P. 06500, Mexico, D.F. T: +52 55 5241 1370 F: +52 55 5241 1371 E: informacion.msmexico@bsigroup.com www.bsigroup..com.mx BSI Brazil Sistemas de Gestäo. Rue Gomes de Carvalho, 1306º – 11 andar Vila Olimpia Säo Paulo SPCEP: 04571-000 Brazil T: +55 11 2148 9600 F: +55 11 2148 9601 E: bsibrazil@bsibrazil.com.br www.bsigroup.com.br

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