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MedDevices Lifesciences Quality & Regulatory Compliance Services for Medical
Devices
Phone: +91-9871231133 Email: info@meddevices.net
MedDevices Lifesciences Quality & Regulatory Compliance Services for Medical
Devices


 * MedDevices Lifesciences Quality & Regulatory Compliance Services for Medical
   Devices
 * Home
 * EAR (EU)
 * UK Responsible Person
 * US FDA Agent
 * US FDA Registration
 * FSC
 * Consultancy
   * CE Marking
   * ISO 13485:2016
     * Cleanroom Validation and Testing: ISO 14644-1
     * Medical Device Ethylene Oxide Sterilization – ISO 11135
   * EN 62304:2006+A1/2015
   * IEC 60601 Pre-Testing
 * Trainings
 * Phone: +91-9871231133 Email: info@meddevices.net


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European Authorised Representative Services
EU Authorised Representative Services

Your Ticket to Selling your Medical Device in EU

Our Services Include:

1. Representing and registration of manufacturer and medical device
2. Guidance in creating technical documentation
3.Reviewing and identifying gaps in your technical documentation
4.Consultation in incident reporting
5.Safeguarding and ensuring compliance with regulatory updates

Appoint Us as Your EAR Now!!
Know More
US FDA Agent Services
US FDA Agent and Registration Services

Your Ticket to Selling your Medical Device in USA

Our Services Include:

1. Manufacturer registration
2. Devices Registration of 510 K exempt Products
3.Devices Registration of 510 K Products
4.Guidance in preparation of technical documentation
5.FDA audit compliance services

Appoint Us as Your US FDA Agent Now!!
Know More
UK Rep Services
UK Responsible Person (UK Rep) Services

Your Ticket to Selling your Medical Device in UK

Our Services Include:

1. Representing and registration of manufacturer and medical device
2. Guidance in creating technical documentation
3.Reviewing and identifying gaps in your technical documentation
4.Consultation in incident reporting
5.Safeguarding and ensuring compliance with regulatory updates

Appoint Us as Your UK Rep Now!!
Know More
Consultancy Services
Consultancy Services

Your One Stop Solution for the Problems related to Medical Devices

Our Services Include:

1. ISO 9001:2015
2. ISO 13485:2016
3. CE Marking
4. IEC 60601 Testing
5. EN 62304:2006+A1/2015

Get an Appointment for Consultation NOW!!
Know More
Free Sales Certificate Services
Free Sales Certificate Services

Your Ticket to Go International

We apply for Free Sales Certificate from our branches in EU and UK. We can also
get your FSCs apostilled and notarized if asked.

Enquire NOW!!
Know More
Trainings
Trainings

Learn and Test Your Knowledge with our Interactive Trainings

Some of the trainings we provide cover topics:

1. ISO 9001:2015
2. ISO 13485:2016
3. ISO 14971:2019
4. UDI-DI etc.

Enquire NOW!!




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WHO WE ARE?

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We are a leading Total Quality Assurance provider specializing in the field of
medical devices industry worldwide. We are one stop solution for inspections,
trainings, CE marking, ISO certifications & testing of electrical &
electromedical products. We provide customized solutions to help you achieve and
effectively maintain your regulatory and commercial success.


OUR SERVICES

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EU AUTHORISED REPRESENTATIVE

We monitor vigilance issues related to your product and are the contact person
on your behalf for European Authorities

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UK RESPONSIBLE PERSON & MHRA REGISTRATION

As UK Responsible Person we act on behalf of the manufacturer under UK MDR 2019
& do registration in MHRA

Read More


US FDA AGENT & REGISTRATION

We do product registration for both 510K exempt and 510K products with US FDA
along with FDA audit compliance services

Read More


FREE SALES CERTIFICATE

We provide FSC from EU and UK for medical devices with apostille, notarization
and legalisation services

Read More


TRAININGS

We provide knowledge based interactive trainings for ISO 9001:2015, ISO
13485:2016, ISO 14971:2019, UDI and other related topics

Read More


CONSULTANCY

Our services cover CE marking & testing for medical devices in addition to
standards like ISO 13485, ISO 9001, ISO 14971 etc.

Read More


OUR CLIENTS

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Some of our most reputed clients include names like

Healthium Medtech

Tynor Orthotics

Unisur Lifecare

SPM Medicare




BECOME OUR CLIENT TODAY!!

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We are a ONE STOP SOLUTION for all your medical device’s needs and problems.

We help you in achieving:

 * Testing and certification for faster regulatory approval
 * Total Quality Assurance across your supply chain
 * Rapid & efficient entry to virtually any market in the world
 * Innovative leadership in meeting social accountability standards
 * Name and fame as a trusted and assured brand in the market
 * Increased Product demand and overall profit

Get a Quote


INDIA OFFICE

MedDevices Lifesciences Private Limited
Unit No. 4F-CS-67, Fourth Floor, Ansal Plaza, Sector-I, Vaishali,
Ghaziabad-201010
+91-9871231133
+91-9316012883
info@meddevices.net


NETHERLANDS OFFICE

Meddevices Life Sciences B.V.
Keizersgracht 482
1017 EG Amsterdam,
The Netherlands
+31202254558
info@meddevices.net


UK OFFICE

MedDevices Services Limited
27,Gloucester Street,
London,
WC1N 3AX
+44 1923 449228
info@meddevices.net


LINKS

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Contact Us
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