Medical Device Consultants
We are leading medical device consultants and serve manufacturers with CE marking, UKCA Mark, US FDA 510k, ISO 13485, 21 CFR 820 certification, and more. Our firm delivers results faster! No matter what the device is or how complex the device’s technology is.
As medical device consultants, we work for clients remotely, but customers can monitor the progress and quality of documentation wherever they are at any point in time.
Experienced medical device consultants with prior experience with a particular device are selected for every project. Each project will be monitored by the team leader.
Every project with us will be taken care of by at least three experts, which assures quality documentation and final review for onward submission to authorities on time.
We support manufacturers, initial exporters, and importers of medical devices intended to be sold in the USA.
Medical device manufacturers must implement and follow ISO 13485 pathway if planning for CE or UKCA marking and certification.
21 CFR Part 820 is very important for medical device organizations that wish to demonstrate applicable regulatory requirements with the FDA.
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.
We are CE marking consultants and help medical device manufacturers commercialize their products in the EU market.
UKCA Mark Consulting helps in the certification process, starting with technical file preparation, testing, and certification body submission.
Medical Device Consultants Role In Healthcare Industry
Medical device consultants are professionals who provide expertise and guidance to companies that develop, manufacture, and market medical devices. We work with a wide range of clients, from small startups to large multinational corporations around the globe. Our role can vary depending on the specific needs of our clients. However, some common tasks that medical device consultants perform include:
- Providing regulatory advice: Medical device consultants can help companies navigate the complex regulatory landscape for medical devices. This includes helping companies obtain the necessary approvals from regulatory agencies, such as the FDA in the United States.
- Providing clinical advice: Medical device consultants can help companies understand the clinical needs of healthcare providers and patients. This includes helping companies design and develop medical devices that are safe and effective.
- Providing commercial advice: Medical device consultants can help companies develop and execute commercial strategies for their products. This includes helping companies market their products to healthcare providers and patients.
In addition to the tasks listed above, consultants may also provide other services, such as:
- Training healthcare providers on how to use medical devices
- Conducting clinical trials
- Writing technical documentation
- Managing regulatory projects
The role of a medical device consultant is becoming increasingly important as the healthcare industry becomes more complex. Medical device consulting is essential for helping companies bring new and innovative medical devices to market.
I3CGLOBAL Expertise as a Medical Device Consultant
Medical device consultants possess a diverse range of expertise that is crucial for guiding manufacturers and stakeholders through the complex landscape of the healthcare industry. One of the key areas of our expertise lies in regulatory affairs. We are well-versed in the intricate and ever-changing regulatory requirements set forth by various global authorities, such as the FDA, EMA, and other regulatory bodies. We help businesses navigate through the regulatory approval process, ensuring compliance with the necessary guidelines and standards, and expediting the market entry of medical devices.
Quality management is another core domain where medical device consultants excel. We offer valuable insights into establishing and maintaining robust quality management systems (QMS). We assist in developing comprehensive quality control measures, adhering to international standards like ISO 13485 and ISO 9001. By implementing an effective QMS, companies can ensure that their medical devices are manufactured, tested, and distributed under controlled conditions, leading to consistent product quality and enhanced patient safety.
How I3CGLOBAL assist manufacturers in obtaining regulatory approvals
I3CGLOBAL Medical device consultants play a vital role in guiding manufacturers through the intricate process of obtaining regulatory approvals and ensuring compliance with global regulations. Our in-depth knowledge of regional and international regulatory requirements, such as those imposed by the FDA in the USA and CE Marking in Europe, is invaluable for businesses seeking to navigate complex regulatory landscapes. We help manufacturers prepare and compile comprehensive regulatory submissions, ensuring all necessary documentation is in place and meeting the specific requirements of each regulatory authority.
Throughout the regulatory approval process, we act as intermediaries between manufacturers and regulatory agencies. We facilitate communication and interactions, assisting with any queries or requests from regulatory authorities. By anticipating potential roadblocks and addressing them proactively, consultants streamline the approval process, reducing delays and expediting market entry for medical devices. Our expertise in compliance and adherence to regulatory standards ensures that medical devices meet all safety, quality, and efficacy requirements, instilling confidence in regulatory authorities and facilitating a smoother path to market access.
Discuss the importance of implementing robust QMS.
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.
Why Choose I3CGLOBAL as your Medical Device Consultants?
We are a team of medical device consultants and provide services in the EU, INDIA, the United States, and the United Kingdom. Our comprehensive regulatory support includes help with technical documentation, testing, clinical evaluation, and european authorized representative services for many countries. I3CGLOBAL is an EN ISO 13485:2016 QMS certified, as well as an ISO 27001:2013 data security system certified company.
We provide complete medical device consulting including US Agent Service along with documentation and FDA Coordination.
The one-Stop service center for all your needs for CE Marking your Medical Device. No matter the risk class or State of the art.
We have in-house EU & UK Representation offices in Germany and UK for MDR and UKCA compliance for medical devices.