The medical device industry is a dynamic and highly regulated sector that plays a critical role in healthcare delivery. From diagnostic tools to life-saving implants, medical devices contribute to improving patient outcomes and enhancing quality of life.
Protheragen-ING Lab specializes in providing comprehensive solutions tailored to the needs of the medical device industry. Whether you are a manufacturer, distributor, or importer, our team of experts is here to support you throughout the entire process.
Our main services in the medical device industry
With our extensive expertise and in-depth knowledge of regulatory requirements, we offer a range of services to assist you in navigating the complex landscape of medical device registration and compliance.
FDA Medical Device Registration
Protheragen-ING Lab will guide you through the Food and Drug Administration (FDA) registration process, ensuring that your medical device meets all necessary compliance requirements for the U.S. market. We will assist you in preparing and submitting the required documentation, including the premarket notification (510(k)) or premarket approval (PMA) application, as applicable.
ISO Medical Device Registration
Protheragen-ING Lab will assist you in achieving International Organization for Standardization (ISO) certification, such as ISO 13485, which is specifically tailored to the medical device industry. We will provide guidance on implementing the necessary quality management systems, conducting audits, and ensuring compliance with ISO standards.
CE Medical Device Registration
Accessing the European market requires compliance with the CE marking requirements outlined in the medical devices regulation (MDR). We guide companies through the CE certification process, helping them meet the necessary conformity assessment procedures and regulatory obligations for marketing medical devices in the European Union.
Our team will guide you through the conformity assessment procedures, including the preparation of technical documentation, assessment of conformity with applicable EU directives and standards, and coordination with notified bodies.
Professional services from registration to listing
we go beyond mere registration assistance. We offer a comprehensive suite of services to support you throughout the entire lifecycle of your medical devices. Our team of regulatory experts, engineers, and consultants are dedicated to providing personalized solutions tailored to your specific needs. Here are some additional services we offer:
- Regulatory Consultation.
- Product Classification.
- Quality Management Systems.
- Labeling and Packaging Compliance.
- Post-Market Surveillance.
Why Choose Protheragen-ING Lab?
- Our team consists of regulatory experts with in-depth knowledge of the medical device industry and a track record of success in navigating complex regulatory landscapes.
- We understand that every client is unique, which is why we offer personalized solutions designed to meet the specific needs and objectives of each company.
- With a focus on regulatory compliance and quality assurance, we help companies mitigate risks and achieve market access for their medical devices with confidence.
- We prioritize responsiveness and efficiency, providing timely support and guidance to expedite the registration process and minimize time to market.
Contact us today to learn more about our services and how we can help you achieve regulatory compliance and commercial success in the medical device industry.