Medical Device Consultants
CE MARKING
TECHNICAL FILE | EAR | TESTING | PMS | PMCF | CLINICAL EVALUATION
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Medical Device Consultants
(EN) ISO 13485:2016
CONSULTING | GAP ANALYSIS | TRAINING | INTERNAL AUDIT
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Medical Device Consultants
US FDA 510k
510k PREPRATION | GUIDANCE | FDA SUBMISSION | US AGENT
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Medical Device Consultants
21 CFR 820 & MDSAP
CONSULTING | TRAINING | GAP ANALYSIS | FDA 483 RESPONSE
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Medical Device Consultants

Are you in search of a Medical Device Consultants to support certification activities for CE Marking or US FDA 510k?

MedDeviceCorp; a firm established in the year 1999, a Global medical Device Consulting firm for the EU and the FDA providing services to worldwide manufacturers from our Germany, India and USA offices.

Our team managers faced more than 3000+ medical device product compliance and system / GMP compliance covering multiple risk categories from multiple countries.

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 the USA, Europe, India, China, Canada, Russia, Britain & Brazil.


Medical Device Consultants for US FDA 510k Compliance

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.

As medical device consultants, we deliver the following services as per US FDA.

  • Medical Device establishment Registration
  • Medical Device Listing
  • US FDA 510k preparation, Submission and FDA communication
  • FDA QSR 21 CFR 820 documentation & Implementation Support
  • Pre- Inspection Support and 483 response.
  • Medical Device Facility /Layout Development and Room Book preparation.

Medical Device Consultants for EU MDR Compliance

European Regulations covering 28 member countries and 5 Candidate countries relating to the safety and performance of medical devices following below directives.


We are a medical device compliance consultant that can deliver technical and scientific guidance and compliance solutions to worldwide medical device manufacturers who are interested in export to Europe.

As a team of consultants, we deliver the following services as per EU MDD and EU new Medical Device Regulations (MDR).

  • MDR CE Marking Technical File Preparation, NB submission and NB coordination till Certification.
  • Meddev 2.7.1 Rev 4 Clinical Evaluation
  • EN ISO 13485:2016 Documentation, Implementation support, Internal Audit and Training.
  • PMS Post Market Surveillance,
  • EN ISO 14971:2012 Risk Analysis.
  • On 5th May 2017, the EU published a new MDR and, new IVDR requirements. 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 offer a one-stop-shop approach designed to help the export of medical devices to the USA and Europe fast by providing complete solutions.

    Our Medical Device Consultants are highly qualified, experienced in medical device Industry and Medical Device Regulatory consulting and Quality Assurance services.

    Please call the nearest office or fill our contact form, we are pleased to help you regrading medical device consulting.


    Recent Client Testimonial...


    Medical Device Consultants Reviewed by Sam James in . Wonderful Consulting Firm. I am happy to recommend MedDeviceCorp to others looking to outsource regulatory work from the USA. Rating: 4.9

    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@meddevicecorp.com