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...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: healthcare@bsigroup.com

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: healthcare@bsigroup.comwww.bsiamerica.com

BSI – Canada6205 Airport Road, Suite 102Mississauga, ON L4V 1E1CanadaTel: 1 800 862 6752Fax: 1 416 620 9911email: inquiry.canada@bsigroup.comwww.bsigroup.ca

BSI – BrazilAvenida Eng Luis BerriniN.º 1400 – 1º Andar – CEP: 04571-000Brookline, Sao PauloSPBrasilTel: +55 13 3223 5770Fax: +55 13 3223 3851email: informacao.msamericas@bsigroup.comwww.bsibrasil.com.br

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: informacion.msmexico@bsigroup.comwww.bsigroup.com.mx

BSI – United KingdomKitemark HouseMaylands AvenueHemel HempsteadHP2 4SQUnited KingdomTel: +44 (0)8450 765600 Fax: +44 (0)8450 765601email: ps.healthcare@bsigroup.com www.bsi-global.com

BSI JAPAN K.K. – JapanToranomon Kotohira Tower 21F1-2-8 ToranomonMinato-kuTokyo105-0001 JapanTel: +81 3 5501 7121Fax: +81 3-5501-7127/7128email: japan.info@bsigroup.comwww.bsi-japan.com

BSI China – Shanghai23/F Evergo Tower1325 Huaihai Middle RoadShanghai 200031ChinaTel: +86 21 6431 2638Fax: +86 21 6474 0635email: sh@bsigroup.com www.bsigroup.cn

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: hk@bsigroup.com 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: bsi.delhi@bsigroup.com www.bsigroup.co.in

BSI – Singapore460 Alexandra Road#08-01/02PSA BuildingSingapore 119963Tel: +65 62700777Fax: +65 62702777email: sgp@bsigroup.comwww.bsigroup.sg