ARE YOU READY TO FACETHE GLOBAL MARKETPLACE?
EXPERTISE • GLOBAL ACCESS • SPEED-TO-MARKET • CONFIDENCE • PARTNERSHIP
...making excellence a habit.
BSI, HEALTHCARE
LET BSI HELP YOU MEET THE WORLDWITH CONFIDENCEVerifying 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 confi rm the products’
readiness for market—effi ciently, 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
Notifi ed Body dedicated to providing
rigorous regulatory and quality
management reviews and product
certifi cations 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
confi dence knowing that we conduct
robust, comprehensive assessments
that will stand up to scrutiny. We are
well-known worldwide for fast, effi cient
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
fi ve 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 offi ces around the
world to serve you.
Speed-to-Market – providing fl exible
solutions for manufacturers needing
accelerated pathways to global markets.
Confi dence – 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.
Benefi ts of Working with an Industry Leader
YOUR NOTIFIED BODY OF CHOICE
• ISO 13485 QMS
• CE Marking
• Health Canada CMDCAS
• Japan PAL
• ISO 14971 Risk Mgt. Certifi cation
• 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 Certifi cation
• 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.
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!
GETTING YOUR PRODUCT TO MARKET IS AS IMPORTANT TO US AS IT IS TO YOU
Programs do not guarantee a CE Marking certifi cate 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 theCE-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.
REGULATORY AND QUALITY MANAGEMENT PROGRAMS AND SERVICES
Product Certifi cation
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-PartyReview 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
Notifi ed Body before they start. This is to
help ensure that once they are completed,
they are acceptable and suffi cient to meet
CE Marking requirements needed by the
Notifi ed 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 Certifi cation 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 ConformityAssessment Body (CAB)
BSI was the fi rst 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.
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 fi t 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 offi cial. 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 fl aws or gaps in the systems that the manufacturer can then correct.
Risk Management Certifi cation
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 Certifi cation provides independent confi rmation 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 confi dence 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 certifi cation 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 fi rst 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 effi ciently.
Please visit our website for additional services.
EXPERIENCE YOU CAN
COUNT ON
The benefi ts of having professional, experienced and well-qualifi ed 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 confi dence 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 fl ow 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 confi dence in a manufacturer’s level of sterilization control could place patient safety in signifi cant 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% confi dence as the ramifi cations 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
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 fi elds 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
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 specifi c 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 fulfi ll the RABQSA training requirements for QMS Auditor and QMS Lead Auditor certifi cation.
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 fl exibility to fi t 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
Contact us
1 800 862 4977
email: [email protected]
www.bsiamerica.com
Let us put our team behind yours.
...making excellence a habit.
BSI, Healthcare12110 Sunset Hills Road, Suite 200Reston, VA 20190-5902USATel: 1 800 862 4977Fax: 1 703 437 9001email: [email protected]
BSI – Canada6205 Airport Road, Suite 102Mississauga, ON L4V 1E1CanadaTel: 1 800 862 6752Fax: 1 416 620 9911email: [email protected]
BSI – BrazilAvenida Eng Luis BerriniN.º 1400 – 1º Andar – CEP: 04571-000Brookline, Sao PauloSPBrasilTel: +55 13 3223 5770Fax: +55 13 3223 3851email: [email protected]
BSI – MexicoTorre MayorAv. Paseo de la Reforma No. 505Piso 41 – Suite C –Col. Cuauhtémoc, C.P. 06500México, D.F.México Tel: +52 55 5241 1370Fax: +52 55 5241 1374email: [email protected]
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BSI JAPAN K.K. – JapanToranomon Kotohira Tower 21F1-2-8 ToranomonMinato-kuTokyo105-0001 JapanTel: +81 3 5501 7121Fax: +81 3-5501-7127/7128email: [email protected]
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BSI Group: Standards • Information • Training • Inspection • Testing • Assessment • Certifi cationCopyright © 2009 The British Standards Institution All Rights ReservedBSI/USA/149/MS/0808/E
The BSI certifi cation mark can be used on your stationery, literatureand vehicles when you have successfully achieved certifi cation.
BSI – Hong Kong19/F AIA Plaza18 Hysan AvenueCauseway BayHong KongTel: +852 3149 3300Fax: +852 2743 8727email: [email protected] www.bsigroup.hk
India – New DelhiBSI India Private LtdThe MIRA Corporate SuitesPlot 1&2 Ishwar NagarMathura RoadNew Delhi 110065 IndiaTel : +91 11 2692 9000Fax: +91 11 2692 9001email: [email protected] www.bsigroup.co.in
BSI – Singapore460 Alexandra Road#08-01/02PSA BuildingSingapore 119963Tel: +65 62700777Fax: +65 62702777email: [email protected]