Business Line Medical
Business Line Medical – Your Notified Body
for worldwide certification.
You manufacture innovative medical devices or in-vitro diagnostics (IVD) and you want to get these products to different markets
quickly. Interactive cooperation with your Notified Body would facilitate your understanding throughout the whole regulatory
process. Wouldn‘t it be convenient to work with an expert Notified Body who has knowledge of your product while recognizing
your needs for time to market? Special expedited programs are available to decrease the time to market for your products.
DEKRA offers one-stop-shopping for the key medical markets in Europe, the United States of America, Canada, Japan, Taiwan,
and Australia. DEKRA knows the medical device world better than most. With our model of dedicated project management,
responsibilities are clear and you get a dedicated DEKRA contact.
Two Notified Bodies act as one
Our characteristics
Both DEKRA Certification and KEMA Quality as part of the
DEKRA Group are Notified Bodies and fully accredited for
the certification of medical devices. DEKRA Certification‘s
service quality will remain on the high level and in addition
your company benefi ts through extendet market access
services of KEMA Quality.
Involves testing and certification of medical devices,
auditing of medical device companies
A leading top 5 global Notified Body in
medical device certification
Recognized market leader in high risk devices
Strong positions in Germany, the Netherlands
and the United States of America
Recognisation by EU, the FDA and Health Canada
Offices in all key markets
With over 150 Medtech/IVD experts who now joined
forces in one globally acting team we can give you a lot
more personal guidance, flexibility and expertise – this is the
DEKRA Business Line Medical.
Our service is rooted in long-term, practical cooperation to
match your situation at any particular time. Neutral and
independent. Target-oriented.
Global Market Access
For access of medical devices to the European Union and associated countries (EEA), DEKRA provides necessary CE certification
under the Medical Device Directive, the Active Implantable Medical Device Directive and the In Vitro Diagnostic Medical Device
Directive. The DEKRA Group covers the full scope under these directives, including medical devices containing material from
animal origin and material from human blood origin. As part of the product approval process, DEKRA offers certification of the
manufacturer’s quality system to the ISO 13485 standard.
An overview of our services and accreditations
Auditing and certification according to the following
standards and requirements:
We hold a full scope accreditation for conformity assessments
to medical device directives:
EN ISO 13485
CMDCAS program
FDA 510(k) reviews
FDA QSIT inspection
Taiwan ISO13485
Japan Pharmaceutical Affairs Law (ISO 13485)
Australia MRA
ISO 9001
ISO 14001
OHSAS 18001
AIMDD 90/385/EEC
MDD 93/42/EEC
IVDD 98/79/EEC
Blood Directive 2000/70/EEC
Animal tissue Directive 2003/32/EEC
Testing and certification
CB
CSA
Harmonised IEC 60601 ff.
Special expertise and knowledge
Cardiovascular surgery
Minimal invasive surgery
Intravascular devices
Dental devices and implants
Drug device combinations
Animal tissue
High-tech start-up companies
Ophthalmic surgery
Wound care products
Orthopaedic and functional implants
DEKRA Certification
The DEKRA seal
Active. Diligent. Visionary.
Whether you are focusing on effi cient business processes,
product and system reliability for your international market
success or qualifi ed experts: With more than 1,000 specialists
worldwide, DEKRA Certifi cation offers you a comprehensive
service on all aspects of quality and performance, safety and
health, sustainability and responsibility.
Offer your customers reliability and quality with our DEKRA seal!
Around 30,000 companies in more than 50 countries are
already using our certifi cations, tests and inspections to
turn their individual goals into reality, quickly and without
complication.
And what can we do for you?
DEKRA Certification GmbH
Handwerkstraße 15 • 70565 Stuttgart • Germany
Fon +49.711.7861-2566 • Fax +49.711.7861-2615
[email protected]
www.dekra-certification.com
The DEKRA seal stands for highest
reliability - across different industries and
internationally. It will create trust and give
your customers the certainty of being on
the safe side.
Our seal will be your strength. Use it as
an image bearer and marketing tool. We
will be pleased to help you.