Medical Device Consultants
We are medical device consultants. Our focus areas are GMP, CE Mark, UKCA Mark, FDA 510k, ISO 13485, and 21 CFR 820 compliance, and more. We deliver results faster, regardless of the device’s complexity or technology.
Medical Device Consultants. How Important they are?
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 medical device consultants typically do:
- Determining the most appropriate regulatory pathway for EUROPE, USA, and UK market entry with product certification such as FDA 510(k), 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 (QMS) Development and Implementation: as per ISO 13485, 21 CFR 820, QMSR, MDSAP standards
- Conducting internal 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 (CAPA) to address non-conformities / 483,s raised by US FDA, Certification Bodies and or Notified Bodies
- Clinical Evaluation Reports (CER) 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 (PER) documentation for Invitro diagnostic devices as per IVDR to support CE Mark submissions and post-market surveillance
- Advising 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
- European Authorized Representative Service, Eudamed and EU Registration for medical and IVD devices
- UK Responsible Person (UKRP) service and MHRA Registration for Medical and IVD devices.
Navigating the complex regulatory landscape of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) requires expertise and thorough understanding. Our team of MDR and IVDR consultants is here to guide you through every step of the compliance journey, ensuring your products meet the stringent requirements for CE marking and EU market access.
Why Choose I3CGLOBAL Team of Medical Device Consultants?
Medical device consultants bring specialized knowledge and extensive experience, which can be particularly valuable for navigating complex regulatory hurdles. With their expertise, consultants can streamline processes and help bring products to market more quickly. Important to note that medical device consultants can be invaluable partners in bringing safe, effective, and compliant medical devices to market, ultimately contributing to improved patient outcomes and business success.
As premier medical device consulting firm, we stand out for several compelling reasons:
- Our team comprises qualified and experienced professionals with extensive knowledge and experience in medical device regulatory requirements.
- We offer a wide range of services, including CE marking, UKCA Mark, US FDA 510k, ISO 13485, 21 CFR 820 certification, and more, providing end-to-end solutions for our clients.
- We pride ourselves on delivering results swiftly, ensuring that our client’s projects stay on track and meet their deadlines.
- Recognizing that every device and client is unique, we provide customized solutions that address specific needs and challenges.
- With a deep understanding of regulatory landscapes worldwide, we help our clients navigate complex compliance requirements effectively.
- A client-centric approach is our focus, and we strive to build long-term relationships based on trust, transparency, and exceptional service.
- Our proven track record of success speaks for itself, with numerous satisfied clients and successful projects under our belt.
- Our team presence in various countries makes us reach customer locations fast in case of any surprise inspection or any other situation.
- Office locations in Germany, India, the UK and the USA. Associated offices in Australia, Malaysia, South Korea and Vietnam.
- We have been in the business since year 1999.
Choose us as your medical device consultants, and experience the difference firsthand.
FDA 510k Consultants for Medical Devices and IVD,s
FDA 510(k) clearance and approval are mandatory for most of the class II and class III medical devices to be sold in the USA.
US FDA 510k for Medical Devices
Navigating the intricate and extensive FDA requirements for 510(k) is key to achieving swift FDA clearance for medical devices. Our service offers unparalleled expertise and insights from the beginning of your 510(k) clearance journey, including device classification, code identification, predicate devices, and assessing potential risks, all the way to the final submission. Our team is committed to preparing all necessary documentation and ensuring compliance with requirements. We will oversee the submission of your 510(k) application to the FDA, serve as your representative, and manage all communications and inquiries to facilitate a smooth clearance process. We are QARA professionals and medical device consultants. Contact us for more information.
Medical Devices and Invitro Diagnostic Device CE Marking
CE marking is a mandatory certification indicating that products sold within the European Economic Area (EEA) comply with MDR/IVDR regulations. For medical devices and in vitro diagnostic (IVD) devices, acquiring a CE mark is an essential step for entering the EEA market. This is where our responsibility begins. Our primary role involves preparing technical documentation by MDR 2017/745 and IVDR 2017/746. Comprehensive documentation is necessary to provide clinical evidence that supports the safety and performance of the device for medical devices, and for IVD, analytical and clinical performance studies are required to prove the device’s accuracy, reliability, and clinical validity. We are EU regulatory experts and medical device consultants. Contact us for more information.
ISO and GMP Consultants for Medical Devices
Implementing a robust Quality Management System (QMS) is of paramount importance for medical device manufacturers to ensure consistent product quality, compliance with regulations, and patient safety. A well-designed QMS provides a systematic approach to managing processes, resources, and responsibilities throughout the entire product lifecycle.
It helps businesses establish standardized procedures for design, development, manufacturing, testing, and post-market surveillance. By adhering to international standards such as ISO 13485, medical device companies can demonstrate their commitment to meeting the highest quality standards and regulatory requirements. A robust QMS fosters a culture of continuous improvement, encouraging businesses to monitor and address any deviations or non-conformities promptly, leading to enhanced product reliability and customer satisfaction.
As a medical device consulting firm, our premium services cover GMP and ISO. A few of our scope detailed below:
- Medical Device Facility Design for any type and risk class of devices
- ISO 13485 Implementation, Guidance, Internal Audit and third-party inspections.
- 21 CFR 820 Implementation, Guidance, Quality Audit
- QMSR/MDSAP Implementation and Audit support
- Closing of FDA 483
- US FDA pre and post-inspection support service
- Multiple Lead auditors and GMP Experts working full-time in 4 global locations.
- Internal Quality Auditor Training
- We have been in the business since year 1999.
Choose us as your medical device QMS/GMP consultants, and experience the difference
ISO 13485, GMP, 21 CFR 820, QMSR, MDSAP Consultants for Medical Devices and IVD,s
Our services for the implementation and certification of medical device quality management systems are in line with product regulatory approvals.
Country Representation Service
In highly regulated markets like the USA, UK, or Europe, the import and sale of medical devices and in vitro diagnostic (IVD) devices are subject to stringent regulatory requirements to ensure safety and efficacy. Here’s an elaboration on the process.
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). Post-Brexit, the UK has its regulatory system distinct from the EU, requiring manufacturers to have a UK Responsible Person for regulatory compliance.
- Europe: In the European Union, manufacturers (Domestic and foreign) must register with the relevant national Competent Authorities. They 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 if the manufacturer is based 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 devices consultants.
FDA 510k Consultants for Medical Devices and IVD,s
FDA 510(k) clearance and approval are mandatory for most of the class II and class III medical devices to be sold in the USA.