Medical Device

Compliance Services

TV Rheinland (India) is one-stop shop for Compliance Testing, Inspection,

Assessment, Training and Certification requirements for Medical Equipment
Design and Manufacturing Companies.

Capabilities
Products
Infant Baby incubator , Infant Baby Warmer,
Infant baby phototherapy, ECG Monitoring and
diagnostics, Medical device anesthesia, Critical
care ventilator, Alarm, X-ray equipments,
Ultrasound and others

Conformity Assessment
European Medical Device Directives (MDD, IVDD,
AIMDD) for CE Marking (CE 0197)
ISO 13485 (including under Canadian Medical
Devices Conformity Assessment Scheme
CMDCAS)

Accreditations

Notified Body under European Union

Simultaneous national certification body for U.S.A, Germany, Japan, Argentina, Hungary and Hong Kong
Accredited by OSHA as a NRTL and Recognized by Standards Council of Canada
Conformity Assessment Body for Malaysia, Saudi Arabia, Brazil and many others
Accredited by IECEE for CB certification for medical devices
In house test facility approved by AERB to conduct Electrical Safety and Radiation Test for x-ray devices

www.tuv.com/in

Engagement Models
Our various engagement models will enable us to assist you throughout the Project Life Cycle.
Developmental Assistance

In DA we provide our laboratory setup with assistance of qualified and

experienced engineers to help you carry out any R&D and developmental
activities and evaluate your product in a more accurate way.

Pre-Compliance Testing

We engage with product development teams at the stage when the product is
in the design and prototype stage and support them with Design Review, Gap
Analysis and perform critical tests as per the reference standard to evaluate the
compliance level while ascertaining the deviations.

Regulatory Compliance
Testing

TUV Rheinland being a third party independent certification laboratory having

accreditations from various regulatory authorities across the globe can assist
you with Compliance Test Reports for global markets. Our strength in this
respect is our laboratory infrastructure, accreditations and network of partner
laboratories that help us act as a single point solution for you when it comes to
regulatory compliance.

Global Market Access

By virtue of our global presence in 500+ locations in 65+ countries and a

network of 100+ laboratories globally having recognition by majority of the
regulatory bodies we can support you with getting your product certified for
global market.

Training

We can assist your product development and engineering team in understanding

the regulatory compliance requirements in depth with respect to your product
portfolio by devising custom made training modules.

Service Porfolio
Safety, Performance
and Environmental
Testing

Gap assessement
Pre-compliance Testing
Regulatory Full Compliance Testing

EMI / EMC

In house Test facility to do EMC testing as per IEC/EN 60601-1-2 4th edition
(Mandatory from 2017 in US for FDA approval and 2019 in European union for
CE mark)
10 meter Anechoic chamber to do all Radiated Emission and Susceptibility tests
Developmental Assistance

Wireless Testing

Bluetooth Low Energy ( BLE ) , Wi-Fi and cellular modules in medical devices
have become integral part and TUV Rheinland has capabilities and expertise in
India to test Wireless devices
Capability to perform Wireless testing as per the latest ETSI and FCC standards
and also Radio Type Approval for 200+ countries.

Training

Global Regulatory Compliance Requirement

Medical Safety Testing Requirements
QMS and ISO 13485

QMS / ISO 13485

Assesment of Quality Management Systems according to ISO 13485 to meet

regulatory requirements
Notified body CE certification program for classified medical devices under
MDD and IVDD

EMC & Wireless for Medical Devices

More and more medical devices are now connected in nature

having bluetooth, Wi-Fi, 3G and other Long range wireless
protocols and due to its critical nature majority of countries
have regulations around wireless protocols. TUV Rheinland is a
frontrunner having state of the art accredited laboratory setups
and experienced team to support global regulatory compliance
programs for wireless medical devices.

Electromagnatic compatibility(EMC) is an integral part of

complaince program for activ medical device testing. TUV
Rheinland is accredited as per ISO 17025 and listed with FCC
and IC for its labs based out of Bangalore to conduct compliance
testing pertaining to EMC.
Capabilities: Radiated & Conducted Emission, Radiated &
Conducted Susceptibility, Electrical Fast Transient, Surge,
Electrostatic Discharge, Dips & Interruptions, Power
Frequency & Pulsed Magnetic Fields Clicks, Disturbance
Power
Laboratories: Testing at 10m/3m Anechoic / shielded
chambers
Design Support: Our facilities can be used for design analysis
On-site Testing: Testing at customer site under special
conditions
Competent Body: For on-site testing or in case of nonharmonized standards
TV EMC Mark: Voluntary third party mark conforming to
EMC regulations

In-house Testing Scope

Standard

Description

Medical electrical equipment

IEC/EN 60601-1

Safety requirements for medical electrical system

Medical electrical equipment

IEC/EN 60601-1-3

Basic safety and essential performance - Radiation

protection in diagnostic X-ray equipment

Medical electrical equipment

IEC/EN 60601-1-8

Tests and guidance for Alarm systems in medical

electrical equipment

Medical electrical equipment

IEC/EN 60601-1-11

Basic safety and essential performance used in

Home healthcare environment

Infant incubators

IEC/EN 60601-2-19

Basic safety and essential performance of Infant

incubators

Electrocardiographs

IEC/EN 60601-2-25

Basic safety and essential performance of

Electrocardiographs

Invasive blood pressure monitoring

equipment

IEC/EN 60601-2-34

Basic safety and essential performance of invasive

blood pressure monitoring equipment

Ultrasonic medical diagnostic and

monitoring equipment

IEC/EN 60601-2-37

Basic safety and essential performance of ultrasonic

medical diagnostic and monitoring equipment

Multifunction patient monitoring

equipment

IEC/EN 60601-2-49

Basic safety and essential performance of

multifunction patient monitoring equipment

Infant phototherapy equipment

IEC/EN 60601-2-50

Basic safety and essential performance of infant

phototherapy equipment

X-ray equipment

IEC/EN 60601-2-54

Basic safety and essential performance of X-ray

equipment for radiography and radioscopy

Pulse oximeter equipment

ISO/EN 80601-2-61

Basic safety and essential performance of pulse

oximeter equipment

Medical Start-Ups Support

Is your company an incubator or medical device start-up company ready to launch new products?
Do you understand the regulatory requirements pertaining to your target markets?
Have you considered pre-compliance, risk management and IEC 60601 and overall product safety?
Dont get overwhelmed!
TV Rheinland can be a powerful regulatory partner to simplify the process. We can help with a faster entry
into the global marketplace by providing aneasy to understandregulatory solution.
Talk to us today to get your product evaluated and prepare for a smooth regulatory compliance and global
market access (Contact: Ms. Bhavya H M - bhavya.hm@ind.tuv.com | +91 7337845200)

TV Rheinland (India) Pvt. Ltd.

82/A West Wing, 3rd Main Road,
Electronic City Phase I,
Bangalore-560 100, India.
Tel # : +91-(0)80 6723 3500 / 3610
Fax # : +91-(0)80 6723 3542
Email: info@ind.tuv.com
Website: www.tuv.com/in

TV, TUEV and TUV are registered trademarks. Utilisation and application required prior approval. CIN: U72501KA1996PTC020653

Products

Rev: 07/2016

TV Rheinland Bangalore lab is accredited for performimg test as per the particular and collateral standards,
following are few standeards for your reference;