Device Information
Type of Device * Select Active Device (Powered) Active IVD Device with Software Software as a Medical Device (SaMD) In Vitro Diagnostic Device (IVD) Non Active Device Sterile Device Implant Device Others This field is required.
Device Class * Select Class I Class II Class III Not Sure This field is required.
FDA Product Code(s)
FDA Regulation Number(s)
Predicate Device 510(k) Number(s)
Number of Models / Variants to be covered in 510(k) * Select Nil 01 02 03 04 Many (explained below) This field is required.
Many Models / Variants? How many?
Intended Use of the Device * This field is required.
Accessories Packed with the Device * Select NIL 01 02 03 04 05 6-10 This field is required.
Components Packed with the Device Select NIL 01 02 03 04 05 6-10
Project Scope
Role of the 510(k) Applicant * Select Design, Develop, Manufacture, QC and Distribute Design, Develop and Distribute, but manufactured in a different facility This field is required.
Role of MedDeviceCorp * Select Guidance + 510(k) Preparation Guidance + 510(k) Preparation + Pre-Submission (Optional) + eSTAR Final Submission + US Agent (Optional) + Answering FDA queries This field is required.
Status of GMP * Select QMSR / 21 CFR 820 / ISO 13485 Implemented QMSR / 21 CFR 820 (In Progress) QMSR / 21 CFR 820 + IEC 62304 Implemented No GMP / QMS Implemented This field is required.
In-House Technical Expert * Select Yes, we have a dedicated in-house product expert who can fully support the MedDeviceCorp team We do NOT have a dedicated technical expert This field is required.
Confidentiality
Customer Confidentiality Commitment. MedDeviceCorp protects all information our customers share with us, including technical files, product details, QMS documents, regulatory records, and business data. When you share information with us, we commit to the following:
Confidentiality: We treat everything you share as confidential.Limited use: We use your information only to deliver the services you have engaged us for.Security: We use appropriate technical and organizational safeguards to protect your information from unauthorized access, loss, or misuse.No unauthorized sharing: We never sell your information or share it without your consent. The only exceptions are when the law requires it, or when sharing it is necessary to deliver your services, for example with regulatory authorities, Notified Bodies, or authorized partners.Your IP stays yours: All designs, processes, and documents remain your property. Sharing them with us does not transfer any ownership rights.Need-to-know access: Only authorized staff who need your information for their work can access it, and they are bound by confidentiality obligations.Retention and disposal: We keep your information only as long as the services or legal requirements need it, and then we securely delete or destroy it.Bound team: Our employees, consultants, and service providers are all bound by confidentiality obligations.Questions: You can contact us at any time with questions or concerns about how we handle your information.
Declaration. MedDeviceCorp takes customer confidentiality seriously and handles all information in line with our contracts and applicable data protection laws. We are also happy to sign a separate Non-Disclosure Agreement (NDA) on request. Where an NDA or data processing agreement has been signed, its terms will also apply.
