1. Active Medical Devices
Flexible, Fastrack solutions from BSI
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
Body worn sensors
RF & Cryosurgery
Heart Lung Machines
and Radip Communication
Clinical Engineering Micro Electronics System Design
Medical Device Engineering
3. Getting your product to market is as
important to us as it is to you
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.
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.
Successful Assessment leads to a Project Manager
recommendation for certification.
Certification Decision Team will review the recommendation file
and if satisfactory approve certification.
Upon successful certification a certificate will be issued to
your company within days.
On –going surveillance audits and reviews monitor for
Your BSI Project Manager is available to support you when
you have questions.
4. Accelerate your product launch with our
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
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.
This premium CE marking programme is for high risk medical
devices requiring design dossier reviews.
BSI knows every day can have an impact on the bottom line,
so we created the CE-45 FastTrack programme.
The CE-90 is our standard Design Dossier service in which
most reviews are completed within 90 working days from
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
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.
Our stringent robust review process combines
speed with experience, integrity, independence and
We focus on establishing a partnership with each
client so we can work together to meet your goals.
Our diverse and experienced team brings in depth
knowledge and understanding of complex medical
We operate in over 100 countries with more than
100 years of experience and offices around the
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
ISO 13485 QMS auditing
Health Canada CMDCAS
FDA 510k Third-Party Review Programme
FDA Accredited Persons Inspections
Australia EU CAB
Hong Kong CAB
Russian Registration Certiﬁcation
CE marking and the Medical Device Directives
Clinical Data Requirements, PMS and Vigilance
Device Drug Combinations
German Medical Device Regulation
BSI - Germany
Hanauer Landstrasse 115
T:7 +49 (0)69 222289 200
F:7 +49 (0)69 222289 300
BSI - Netherlands
Adam Smith Building
T:7 +31 (0)20 346 0780
F:7 +31 (0)20 346 0781
BSI - EMEA
Milton Keynes MK5 8PP
T:7 +44 (0)845 080 9000
F:7 +44 (0)1908 814920
BSI Group America Inc.
12110 Sunset Hills Road,
T: 1 800 862 4977/703 437 9000
F: 1 703 437 9001
BSI Group Canada Inc.
6205 Airport Road,
Suite 102 Mississauga,
ON L4V 1E1,
T: 1 800 862 6752
F: 1 416 620 9911
BSI Group Mexico, S. de R.L. de CV.
Av. Paseo de la Reforma No. 505,
Piso 41 – Suite C
Col. Cuauhtemoc, C.P. 06500,
T: +52 55 5241 1370
F: +52 55 5241 1371
BSI Brazil Sistemas de Gestäo.
Rue Gomes de Carvalho,
1306º – 11 andar Vila Olimpia
T: +55 11 2148 9600
F: +55 11 2148 9601