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ApicalQuality Agreement

EX-10.4 7 e14815ex10-4.htm QUALITY ASSURANCE AGREEMENT


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Exhibit 10.4







Apical Quality Agreement

This Quality Agreement ("Agreement") is made on 12/21/2020 by and between Nexalin and Apical Instruments ("Apical").



The objectives of this Quality Assurance Agreement are to:

establish a collaborative partnership
define responsibilities
assure that all quality requirements concerning the Nexalin Products are met
ensure that operations between Apical and Nexalin run smoothly.

This Quality Assurance Agreement defines the Quality relationship only and is supplementary to existing and future Agreements which describe the business Terms and Conditions.



This Quality Assurance Agreement applies to all Nexalin products.


3Quality Agreement

Nexalin is responsible for overall compliance to applicable regulations. Apical will maintain the Nexalin Quality System, Design History File (DHF) and the Device Master Record (DMR) for Nexalin.

Apical agrees to notify Nexalin's Quality prior to implementation of any changes to the purchased product such as materials used or configuration or site of manufacture. This will allow Nexalin to determine the overall impact, if any, of the changes to Nexalin's product.



Nexalin will qualify and approve Apical by use of one of the following activities:

Oversight of first articles inspection
Design Verification
Process Validation



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Ongoing Apical qualification and approval will be based upon the following sources of feedback:

Periodic Apical audits
Periodic inspections of received product
Customer feedback investigations
Ability of Apical to meet delivery expectations


The attached table details the QSR responsibilities and authorities under this agreement.





QSRarea Nexalin Apical Plan/Notes


Subpart A - General Provisions

§ 820.1 - Scope X X

Both Nexalin and Apical shall have independent Quality Systems .


Apical shall be ISO 13485 certified prior to release of any product for commercial distribution to the European market. If Nexa lin is classified as a Class II device in the European market, they shall be certified to ISO 13485 prior to release to that market.

§ 820.3 - Definitions X X








§ 820.5 - Quality system




















Subpart B - Quality System Requirements

§ 820.20 - Management responsibility





Both parties are expected to have a management responsibility process


§ 820.22 - Quality audit





Both parties are expected to have an internal audit process.



§ 820.25 - Personnel







Apical shall be able to demonstrate compliance for manufacturing and quality staff.
Subpart C - Design Controls



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QSRarea Nexalin Apical Plan/Notes












§ 820.30 - Design controls












X       X

All design control for the product is managed by Apical. If Apical believes design changes are

needed , they will discuss with Nexalin and await formal notification of design ECO approval before implementation.


Manufacturing changes shall be documented in the Apical Quality system . Nexalin must be a

signatory for all manufacturing changes.


Subpart D - Document Controls





§ 820.40 - Document controls






Apical is responsible for controls on documents associated with manufacturing (e.g. OHR,

component specifications, DMR documents).


Subpart E - Purchasing Controls









§ 820.50 - Purchasing controls









X       X

Nexalin will use a purchase order or equivalent to request parts manufacture. Apical will maintain purchasing control records for materials and parts purchased for the manufacture of the parts.


Apical is responsible for Apical approvals of all purchased parts/services for the product.

Subpart F - Identification and Traceability




§ 820.60 - Identification





Apical shall be compliant with identification requirements during product manufacturing, including assignment of serial numbers.


§ 820.65 - Traceability


NIA - Traceability requirements are

only required for surgical implants.

Subpart G - Production and Process Controls



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QSRarea Nexalin Apical Plan/Notes
§ 820.70 - Production and process controls




Apical will have full responsibility.

§ 820.72 - Inspection, measuring , and test equipment




Apical will have full responsibility.




§ 820.75 - Process validation





Apical will have full responsibility. The only anticipated process validation is the overall assembly

process validation.


Subpart H - Acceptance Activities


§ 820.80 - Receiving, in-

process, and finished device






Apical will have full responsibility. Apical will generate a certificate of conformance (CoC) for each device

that will be provided to Nexalin.

§ 820.86 - Acceptance status X Apical will have full responsibility.
Subpart I - Nonconforming Product









§ 820.90 - Nonconforming product










Non-conforming product reports will be generated by Apical.


Apical will provide periodic summaries of nonconforming product reports as feedback to Nexalin.


Apical shall also maintain a nonconforming product process.


Subpart J- Corrective and Preventive Action



§ 820.100 - Corrective and preventive action



X       X

Apical and Nexalin will each maintain a CAPA process.
Subpart K - Labeling and Packa.2:in 2; Control




& 820.120 - Device labeling




X       X

Nexalin is responsible for designing the labeling, but may enlist Apical ' s help. Apical is responsible for all other elements

of this cla use .



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QSR area Nexalin Apical Plan/Notes





§ 820.130 - Device packa£.ing





X       X

Nexalin is responsib le for design and verifying packaging design but may enlist Apical's help.


Apical is responsible for all other packaging operations.


Subpart L - Handling, Storage, Distribution , and Installation

§ 820.140 - Handling X Apical will have full responsibility .
820.150 - Stora£.e X Apical will have full responsibility.





§ 820.160 - Distribution






Nexalin has full responsibility for distribution.


Apical will provide a copy of the packing slip and CoC for each unit

distributed to Nexalin


§ 820.170 - Installation



Nexalin has full responsibility for insta llation.


Subpart M - Records

§ 820.180 - General requirements


X       X

Each company is required to maintain records per this claus e.




§ 820.181 - Device master record.






Apical will finalize , release, and maintain the DMR. Nexalin representative must be a signatory

on the DMR and associated documents .


§ 820.184 - Device history record




Apical will maintain the original records for OHR. A copy will be provided to Nexalin.


§ 820.186 - Quality system record


X       X

Apical shall maintain Nexalin ' s

QSR per the requirements of this clause.






§ 820.198 - Complaint files






X       X

Nexalin will have full responsibility for complaint handling .


Apical may be asked to participate

in investigations and/or corrective actions .

Subpart N - Servicing



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QSRarea Nexalin Apical Plan/Notes



§ 820.200 - Servicing




The seivicing of returned devices

shall follow Apical's Servicing Process.


Subpart O - Statistical Techniques



§ 820.250 - Statistical techniques




X       X

Nexalin and Apical will comply with this clause as appropriate in their operation (e.g. sampling




§ 830 - Unique Device Identification





X       X

Nexalin is responsible for obtaining the UDI prefix and registering with FDA. Apical is responsible for generation and application of UDI





ISO 14971 - Risk Management



X       X


Nexalin will have a Risk

Management File. Apical will maintain the file for Nexalin.




IEC 62304 and 62366






Nexalin will have full

responsibility for compliance to these standards.



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Apical Instruments   Nexalin

2971 Spring St

Redwood City, CA 94063


1776 Yorktown, Ste 550

Houston, TX., 77056

Kim Khoe   John P. Claude
Name   Name
/s/ Kim Khoe   /s/ John P. Claude
Signature   Signature
Director RAQA   Consulting Engineer
Title   Title
12/21/2020   12/21/2020
Date   Date
N/A   N/A
Tax ID Number (if available)   Tax ID Number (if available)