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Skip to content 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 facebook twitter youtube linkedin Check Certificate 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!! -------------------------------------------------------------------------------- WHO WE ARE? -------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------- EU AUTHORISED REPRESENTATIVE We monitor vigilance issues related to your product and are the contact person on your behalf for European Authorities Read More 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 -------------------------------------------------------------------------------- Some of our most reputed clients include names like Healthium Medtech Tynor Orthotics Unisur Lifecare SPM Medicare BECOME OUR CLIENT TODAY!! -------------------------------------------------------------------------------- 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 About Us Contact Us Privacy Policy Terms & Conditions Get Your Medical Device Tested © All rights reserved by Meddevices Lifesciences facebook twitter youtube linkedin Search Search for: Go to top Help Desk