Medical Device Services
Medical Devices and Quality Management
Systems Certification
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Service Overview Medical Device Services

MEDICAL DEVICE SERVICES
BUSINESS LINESSERVICESSERVICES AREAS

ISO 13485
Certification

CE Certification
IVDD/IVDR

2Service Overview Medical Device Services

Medical Device
Single Audit
Program(MDSAP)

CE Certification
MDR

ISO 13485 Certification

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Service Overview Medical Device Services

ISO 13485 Certification

DEKRA ISO 13485
Certification•DEKRA’s team checks,
assesses and, whereappropriate, certifies
compliance with the ISO
13485 requirements.

•DEKRA is an accredited
certification body thatprovides ISO QMS
certification, optionallycombined with MDSAP, TCPand/or CE certification.

•DEKRA can include
compliance with key
standards for the MedicalDevice industry in the scopeof the ISO 13485 certification.

Benefits
 Proof of compliance with the relevant management system guidelines for thedevelopment, manufacturing and distribution of medical devices.
 Increased operational efficiency and lower risks.
 Concrete basis to demonstrate a regulatory compliant and quality-focused
approach to medical device design, development and manufacturing.
 Potential competitive advantages and winning new customers.

4Service Overview Medical Device Services

Medical Device Single Audit Program (MDSAP)

5Service Overview Medical Device Services

Medical Device Single Audit Program (MDSAP)DEKRA Medical Device
Single Audit (MDSAP)6•DEKRA is a recognized
MDSAP independent auditingorganization.

•DEKRA’s team checks andassesses, where appropriate,
certifies compliance with the
MDSAP requirements.

•

DEKRA’s experts haveextensive knowledge of andexperience with MDSAP and
the requirements of theparticipating Regulatory
Authorities: TGA in Australia,
ANVISA in Brazil, HealthCanada, MHLW and PMDA inJapan and FDA in the USA.

Service Overview Medical Device Services

Benefits
 Fulfil all the compliance requirements in the Medical Device Single Audit
Program (MDSAP) and participating regulatory authorities.
 Avoid multiple audits by each participating regulatory authorities, thereby
reducing the number of annual audits and accelerating market entry.
 Mandatory for medical devices in Canada; advantageous for Australia, Brazil,
Japan and USA.

CE Certification MDR

DEKRA CE Certification
MDR•

DEKRA has two NotifiedBodies (in Germany and theNetherlands) designated tooffer conformity assessmentof medical devices under theMDR so manufacturers canaffix the CE marking to theirproducts for access to theEEA market.

•DEKRA’s experts check andassess the conformity ofcustomers’ products with allapplicable requirements.

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Global coverage for on-site
auditing of the development
and production facilities.

Service Overview Medical Device Services

Benefits
 Certification according to the requirements of the new MDR.

 Confirmation that the medical device meets the applicable requirements.
 Proof of compliance with the relevant EU safety requirements.
 Better access to markets adopting and/or recognizing the EU requirements
including the EEA.

CE Certification IVDD/IVDR

9Service Overview Medical Device Services

CE Certification IVDD/IVDRDEKRA CE Certification
IVDD/IVDR
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DEKRA has two Notified Bodies
designated to offer conformity
assessment of in vitro diagnostic
medical devices under theIVDD (Notified Body in theNetherlands only) and IVDR
(Notified Body in Germany andeventually in the Netherlands),
allowing manufacturers to affix
the CE Marking to their products
for access to the EEA market.
DEKRA’s experts check andassess the conformity ofcustomers’ products with allapplicable requirements.
Global coverage of on-site
auditing of the development
and production facilities.

Service Overview Medical Device Services

Benefits
 Confirmation that the in vitro diagnostic medical device meets the applicablerequirements.
 Proof of compliance with the relevant EU safety requirements.
 Better access to markets adopting and/or recognizing the EU requirements,
including the EEA.