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Active Medical DevicesFlexible, Fastrack solutions from BSI
BSI: Expertise and experience Supporting life
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 DevicesPatient 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
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.
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 trainingMedical 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 ReviewThis 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.
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.
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.
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
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BSI - Germany Eastgate Hanauer Landstrasse 11560314 Frankfurt Germany
T: +49 (0)69 222289 200 F: +49 (0)69 222289 300 E: [email protected]
www.bsigroup.de
BSI - Netherlands Adam Smith Building T.R.Malthustraat 3c Amsterdam 1066 JR The Netherlands
T: +31 (0)20 346 0780 F: +31 (0)20 346 0781 E: [email protected]
www.bsigroup.nl
BSI - EMEA Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP United Kingdom
T: +44 (0)845 080 9000 F: +44 (0)1908 814920 E: [email protected]
www.bsigroup.com
BSI Group America Inc.12110 Sunset Hills Road, Suite 200Reston, VA 20190-5902 USA
T: 1 800 862 4977/703 437 9000F: 1 703 437 9001E: [email protected]
www.bsiamerica.com
BSI Group Canada Inc.6205 Airport Road, Suite 102 Mississauga, ON L4V 1E1, Canada
T: 1 800 862 6752F: 1 416 620 9911E: [email protected] 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 CCol. Cuauhtemoc, C.P. 06500, Mexico, D.F.
T: +52 55 5241 1370F: +52 55 5241 1371E: [email protected]
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 9600F: +55 11 2148 9601E: [email protected]
www.bsigroup.com.br