Medical BSI Experience

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Active Medical Devices Flexible, Fastrack solutions from BSI BSI: Expertise and experience Supporting life

Transcript of Medical BSI Experience

Page 1: Medical BSI Experience

Active Medical DevicesFlexible, Fastrack solutions from BSI

BSI: Expertise and experience Supporting life

Page 2: Medical BSI Experience

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

Page 3: Medical BSI Experience

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.

Page 4: Medical BSI Experience

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.

Page 5: Medical BSI Experience

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.

Page 6: Medical BSI Experience

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