CE MARKING

CE MARKING
TECHNICAL FILE | EAR | TESTING | PMS | PMCF | CLINICAL EVALUATION

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ISO 13485

(EN) ISO 13485:2016
CONSULTING | GAP ANALYSIS | TRAINING | INTERNAL AUDIT

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US FDA 510k

US FDA 510k
510k PREPRATION | GUIDANCE | FDA SUBMISSION | US AGENT

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21 CFR 820 & MDSAP

21 CFR 820 & MDSAP
CONSULTING | TRAINING | GAP ANALYSIS | FDA 483 RESPONSE

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Medical Device Consultants for CE, ISO 13485 & FDA 510k

Modern healthcare across all continents depends on the use of sophisticated devices for patient care and cure. Unlike drugs, the  primary mode of action of devices is not pharmacological, immunological or metabolic.

Manufacturing or Marketing of medical devices is controlled by regulatory authorities in each country. The major medical device markets are USA, Europe, India, China, Canada, Russia, Brazil.

Medical Device Consultants for United States of America (US FDA Consultants)
US FDA's Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. We are Medical Device Consultants who can deliver Technical and Scientific guidance and compliance solution to worldwide Medical Device manufactures who are interested to export to USA.

As a Medical Device Consultants we deliver the following services as per US FDA.

Medical Device Consultants for Europe (EU MDD & MDR Consultants)
European Regulations covering 28 member countries and 5 Candidate countries relating to the safety and performance of medical devices following below directives.

We are Consultants who can deliver Technical and Scientific guidance and compliance solution to worldwide Medical Device manufactures who are interested to export to Europe. As a Medical Device Consultant we deliver the following services as per EU MDD and EU new Medical Device Regulations (MDR).

On 5th May 2017, the EU published a new MDR and, a new IVDR requirments. MDR will replace the EU's current MDD 93/42/EEC and the AIMD Directive 90/385/EEC and, the IVDR will replace the EU's current directive 98/79/EC with a 3-year transitional period. .

We Medical Device Consultants offers one-stop-shop approach designed to help the export of medical devices to USA and Europe fast by providing complete solutions.

I 3 Consulting team of Medical Device Consultants are highly qualified, experienced in medical device Industry and Medical Device regulatory and quality Assurance. We have a pool of 26+ consultants, Medical Writers, Lead Auditors in Germany, India & USA.

I 3 Consulting team of Medical Device Consultants and team managers faced more than 3000+ device product compliance and system / GMP compliance covering multiple risk categories from multiple countries.

In search of Medical Device Consultants or any clarification please call to our nearest office or fill our contact form, we are pleased to help you.

INDIA -Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA -Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY-Bremen
+49 2161 990 8831
Phone / WhatsApp

enquiry@i3cglobal.com

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