OUR SERVICES
We offer specialized regulatory consulting services for the registration and maintenance of medical devices with the United States regulatory authority (FDA).
In a business where quality and safety come first, we provide the necessary tools to overcome any challenge.
01 Regulatory Consulting
Specialized Regulatory Assessment Service for Medical Devices, designed to identify and address common obstacles in the registration processes with the U.S. regulatory authority, the FDA.
Our service includes:
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Medical device classification: determining the applicable regulatory class.
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Documentation Review: evaluating the existing supporting documentation.
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Gap analysis: developing a detailed report on the current regulatory compliance status.
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Customized action plan: providing strategies to address identified gaps.
This service is ideal for manufacturers and developers aiming to streamline their market entry while ensuring compliance with required regulations.
02 Medical Device Registration
We provide expert support to register your medical devices in the U.S., ensuring an efficient process fully compliant with current regulations.
Our service includes:
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Medical device classification: determining the appropriate device class.
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Regulatory strategy development: developing a tailored strategy for registration with regulatory authorities.
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Document management: Identifying and evaluating the required documentation.
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Submission preparation and filing: compiling and submitting the application file to the relevant regulatory authority.
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Results analysis and support: advising on resolving feedback or additional requests from regulators.
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Regulatory coordination management: acting as the regulatory point of contact between your company and health authorities.
Our comprehensive approach helps you optimize time and resources, enabling smooth market entry with full regulatory compliance.
03 Quality Management System
We assist you in implementing and optimizing your Quality Management System (QMS) in full compliance with the regulations required by leading health authorities, including:
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ISO 13485: Quality Management System for medical devices.
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MDSAP: Medical Device Single Audit Program.
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21 CFR 820 (FDA): Quality regulations in the United States.
Our service includes:
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Current system assessment: identification of strengths and areas for improvement.
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QMS design and development: implementation of systems in accordance with applicable regulations.
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Gap action plan: customized strategies to meet regulatory requirements.
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Internal audits: conducting virtual or onsite audits to ensure compliance.
04 US Agent & Establishment Registration and Device Listing – FDA
If your company does not have a physical address in the United States, SANRUBIO Medical Devices Consulting can act as your US Agent with the FDA, facilitating communication and regulatory compliance.
We also assist you in meeting FDA requirements for establishment registration and device listing, ensuring access to the U.S. market.
US Agent services include:
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Communication Management: Facilitating information exchange between the FDA and your company.
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Inquiry response: addressing questions regarding imported devices or those in the process of importation to the U.S.
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Inspection coordination: assisting with scheduling inspections at foreign establishments.
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Critical information receipt: serving as the point of contact to receive FDA documents or notifications when direct communication is not possible.
Important: The US Agent does not hold responsibilities related to adverse event reporting (21 CFR Part 803) or submission of premarket notifications 510(k) (21 CFR Part 807, Subpart E).
Establishment Registration includes:
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Annual registration of the establishment in the FDA FURLS/DRLM system.
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Device listing.
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US Agent designation, if applicable.