I3CGlobal Medical Device Consultants and Our Core Competence

🇺🇸 US FDA Regulatory Support – United States

Entering the US medical device market requires a clear FDA regulatory strategy and full compliance. I3CGLOBAL provides complete end-to-end FDA regulatory support, including:

Navigating FDA requirements for a 510(k) submission is challenging for most of the medical device manufacturers. The process involves several steps, including identifying the correct device classification, selecting the appropriate product code, finding suitable predicate devices, and understanding possible method including pre-submission. At I3CGLOBAL, we support companies throughout the entire 510(k) process from the early planning stage to the final submission to the FDA. Our team prepares and not helps manufacturers in documentation, and ensure that the submission meets FDA expectations. With more than 25 years of regulatory consulting experience, I3CGLOBAL has assisted many manufactures in successfully obtaining FDA 510(k) and entering the US market.

🇪🇺 MDR & IVDR CE Marking Support – Europe

Entering the European medical device and in vitro diagnostic market requires CE certification (or self-declaration, where applicable) and proper affixing of the CE mark.

I3CGLOBAL provides complete end-to-end EU regulatory support, including:

CE marking is required for medical devices and in vitro diagnostic (IVD) devices that are sold in the European Economic Area (EEA). CE Mark on the product confirms the requirements of the European MDR or IVDR regulations and can legally be placed on the market. For manufacturers, obtaining a CE mark is an important step before entering the European market. The process involves preparing proper technical documentation and demonstrating that the device meets safety and performance requirements. I3CGLOBAL supports manufacturers throughout this process. With more than 25 years of regulatory consulting experience, our team has helped companies achieve over 400 CE certifications covering more than 1,600 medical devices across different risk classes.

🇬🇧 UKCA Marking Support – Great Britain

Entering the Great Britain medical device and in vitro diagnostic market requires UKCA certification (or self-declaration, where applicable) in compliance with UK MDR requirements.

I3CGLOBAL provides complete end-to-end UKCA regulatory consulting services, including:

With the introduction of the UKCA in the United Kingdom after Brexit, manufacturers who wish to place medical devices in the UK market must follow the UKMHRA requirements. This requirment covers classification, technical documentation, MDQMS, and certified with approved UK bodies. I3CGLOBAL supports both domestic manufacturers in the UK and foreign manufacturers who want to enter the UK market. We help manufacturing companies understand the UKCA regulatory pathway. We guide them in preparing the required documents and making sure their medical devices follow the UK medical device regulations. With many years of experience in medical device regulatory consulting, our team works to make the UKCA certification process simple and faster for manufacturers who want to export their products to the United Kingdom or manufacture medical devices in the UK.

Why Leading Manufacturers Choose I3CGlobal Medical Device Consultants

Partner with I3CGlobal Medical Device Consultants for FDA 510k, EU MDR, IVDR, UKCA and ISO 13485/GMP/QMSR compliance. Our proven expertise helps manufacturers launch safe, compliant products across global markets.

Medical device consultants play a crucial role in the development, regulatory compliance, and market strategy of medical devices. They provide expertise and guidance to companies at various stages of the product lifecycle, ensuring that medical devices meet industry standards and regulatory requirements, and successfully reach the market. Here’s an overview of what consultants typically do:

Medical device consultants determining the most appropriate regulatory pathway for EUROPE, USA, and UK market entry with product certification such as FDA 510k, PMA, CE Marking, and UKCA.
Assisting with the technical documentation preparation and submission for the above product certification and clearances
Acting as Regulatory Liaison agents between the company and regulatory bodies like the FDA, NB, UKMHRA, EMA, or other Competent authorities
Medical Device Quality Management System Development and Implementation: as per ISO 13485, 21 CFR 820, QMSR, MDSAP standards
Medical Device Consultants conductinternal audits and or Quality Audits on behalf of manufacturers or third parties to ensure ongoing compliance with QMS requirements is effective
Assisting with Corrective and Preventive Actions to address non-conformities / 483,s raised by US FDA, Certification Bodies and or Notified Bodies
Clinical Evaluation Reports documentation for medical devices as per MDR and MEDDEV 2.7.1 REV 4 to support CE Mark submissions and post-market surveillance
Performance Evaluation Reports documentation for In-vitro diagnostic devices as per IVDR to support CE Mark submissions and post-market surveillance
Medical Device Consultants advise on design and development processes to ensure FDA and EU product compliance
Device use hazard analysis, conducting risk mitigation activities and developing risk management plans according to ISO 14971
Offering process owner training sessions on regulatory requirements
Establishment Registration and device listing in the US FDA
EU Representative Service, EUDAMED and EU Registration for medical and IVD devices
UK Responsible Person service and MHRA Registration for Medical and IVD devices.

Medical Device Consultants For GMP and ISO

GMP / QMSR

Medical Device Facility Layout design and Infrastructuer consultation in line with global GMP standards.

MDSAP / 13485

Complete technical support for Medical Device Quality Management System Implementation and Audit.

3rd Party Audit

Customer Audit / Vendor Audit / 3rd Party Audit for sale / purchase/ selction of vendors or for outsourcing of manufacturing.

US-FDA Audit

FDA 483 closure and Pre and post FDA audit service

For medical device manufacturers, having a good Medical Device Quality Management System (MDQMS) is very important. It helps maintain consistent quality by complying all regulations, and most important customer satisfaction A properly implemented MD-QMS helps the organization manage its processes, resources, and responsibilities in an organized way. It guides the company in handling different activities such as design, manufacturing, documentation, and product monitoring throughout the entire life cycle of the medical device. By following a structured MD-QMS, manufacturers can improve control over their operations and ensure safety, reliability and quality

QMS helps business establish standardized procedures and protocols for critical process and post-market surveillance. By adhering to international standard ISO 13485, medical device manufactures can demonstrate their commitment to patients and others.

Medical Device Consultants with In-country Representation Service for UK, EU and USA

In highly regulated markets like the USA, UK, or Europe, the import and sale of medical devices and in vitro diagnostic (IVD) devices are regulated by respective authorities to ensure safety and quality. I3CGlobal medical device consultants scope of related services explained below.

Establishment Registration of the Manufacturer / Importer

USA: In the United States, the manufacturer, Initial Importer and Initial Exporter of a medical device must register with the Food and Drug Administration (FDA). This process is known as Establishment Registration. The manufacturer must provide detailed information about its facilities, and the devices it plans to produce and or export to the USA. Foreign manufacturers must appoint a US Agent for registration by law.

UK: In the United Kingdom, manufacturers and importers must register with the Medicines and Healthcare Products Regulatory Agency (MHRA). this new rule stared after Post-Brexit. This UK regulatory system distinct from the EU, requiring manufacturers to have a UK Responsible Person (UKRP) for regulatory compliance.

Europe: In the European Union, manufacturers (Domestic and foreign) must register with EUDAMED instead of the relevant national Competent Authorities earlier. Sellers also need to comply with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), which mandates the designation of a European Authorized Representative (EAR) if the manufacturer is located outside the EU.

Device Listing:

USA: After establishment registration, manufacturers must list their devices with the FDA. This process is called Device Listing. The device listing ensures that the FDA has a comprehensive record of all devices available on the market.

UK: Similarly, in the UK, devices must be listed with the MHRA. This involves submitting information about the device, including its risk classification and GMDN Code.

Europe: In the EU, devices must undergo a conformity assessment process to ensure compliance with the MDR or IVDR. The device must then be listed in the EUDAMED database, which is an EU-wide database of medical devices.

For further details on representative services, please reach out to us. We are not a legal practice or import agent offering registration services. Instead, we specialize as professional QARA experts and medical device consultants.