FDA Medical Device Regulatory Consultant - Private-Label Wound Care Product Import & UDI/GUDID Setup

We are a U.S.-based healthcare products company preparing to import and distribute private-label/OEM wound care supplies manufactured overseas. The products may include collagen wound dressings, foam dressings, alginate dressings, PHMB wound rinse, collagen particles/powder, and related wound care products. We need an experienced FDA medical device regulatory consultant to help us confirm and complete the required U.S. compliance steps before production, labeling, importation, and distribution. The manufacturer states that similar products are already being sold in the U.S. under other white-label brands. However, because the products will be sold under our own private-label brand, we need professional guidance to confirm our responsibilities as a U.S. importer, private-label distributor, labeler, and/or specification developer. Scope of Work: The selected consultant should be able to assist with: Reviewing our role and confirming whether we need FDA establishment registration as an importer, labeler, specification developer, relabeler, repackager, or other applicable category. Reviewing the manufacturer’s FDA registration, device listing, product codes, classification, 510(k) clearance or exemption status, and related compliance documentation. Preparing a product-by-product regulatory compliance matrix for all proposed wound care products and sizes. Advising whether each product is legally marketable in the U.S. under the proposed private-label arrangement. Advising on FDA device listing requirements, if applicable. Advising on GS1/GTIN setup and UDI requirements for the private-label products. Assisting with GUDID account setup and/or GUDID submissions, if required. Reviewing proposed U.S. labels, packaging, UDI placement, claims, intended use, expiration, lot/batch information, manufacturer/importer information, and country-of-origin information. Preparing a checklist of required manufacturer documents before production and shipment, including ISO 13485, technical files, sterilization validation, shelf-life documentation, certificates of analysis/conformity, and batch documentation. Advising on FDA import readiness and coordinating requirements with an FDA-capable customs broker, if needed. Identifying any major compliance risks before we sign the supplier/manufacturer agreement. Ideal Candidate: We are looking for someone with direct experience in: FDA medical device establishment registration and device listing U.S. medical device import compliance Private-label or OEM medical device products Wound care products, dressings, sterile supplies, collagen dressings, alginate dressings, foam dressings, or similar products FDA product classification and product codes 510(k) exemption/clearance review UDI, GTIN, GS1, and GUDID Medical device labeling review Supplier qualification documentation Deliverables: Please include the following deliverables in your proposal: Initial compliance assessment of our planned private-label wound care product import/distribution model. Written summary of our FDA registration/listing obligations. Product-by-product compliance matrix. Manufacturer document request checklist. UDI/GTIN/GUDID action plan. Labeling review notes and required corrections. Step-by-step action plan before production and first import shipment. Optional support with FDA registration, GS1/GTIN setup, and GUDID submission. Important: We are not looking for general business advice. We need someone with real FDA medical device regulatory experience who can review manufacturer documentation and guide us through the correct U.S. compliance process. Please answer the following in your proposal: Have you handled FDA registration/listing for U.S. importers of private-label medical devices? Have you worked with wound care products or sterile wound dressings? Have you completed UDI/GUDID submissions before? Can you review 510(k) exemption or clearance status? Can you provide a fixed-fee quote for an initial compliance review? What documents would you need from us and the overseas manufacturer to begin? What is your estimated timeline for the initial review? We prefer a fixed-price initial review, with the option to continue hourly or milestone-based for implementation.