Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs		 O 408 733 1199
F 408 730 5959
 info@antrix.com

Verification and Validation of Medical Device and Research Use Only (RUO) Products

1. Service Description

The purpose of this service is two fold

  1. To describe the approach for design verification of the product. The verification plan for your product shall serve as a guide in the testing that confirms that the design output meets the design requirements
  2. To describe the approach for design validation of the product. The validation plan for your product shall serve as a guide in the testing that confirms that the product conforms to defined user needs and intended uses.  Design Validation shall include testing of the product under actual or simulated conditions of customer use.

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 40 % > 60 % > 80 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach

Our verification and validation approach of new medical device under development is as follows:

Verification Steps

  1. Document Completion Schedule
  2. Design Verification Protocol Planning
  3. Criteria for Verification Entry
  4. Pass / Fail Criteria
  5. Verification Deviation Management
  6. Tools, Techniques and Methods
  7. Verification Environment
  8. Schedule for Verification Activities
  9. Design Verification Resources and Responsibilities
  10. Other Guidelines

Verification Reports

  1. Design Verification Protocol / Report List and Status
  2. Verification Deviation Management
  3. Verification Summary Report

Validation Steps

  1. Document Completion Schedule
  2. Design Validation Protocol Planning Table
  3. Criteria for Validation Entry
  4. Pass / Fail Criteria
  5. Validation Deviation Management
  6. Tools, Techniques and Methods
  7. Internal and External Customers
  8. Customer Site Management     
  9. Validation Environment
  10. Schedule for Validation Activities
  11. Design Validation Resources and Responsibilities
  12. Other Guidelines
  13. Report

Validation Reports

  1. Design Validation Protocol / Report List and Status
  2. Validation Deviation Management
  3. Validation Summary Report

4. Definitions

Design Verification:  Confirmation that the design output meets the design requirements.

Design Validation:  Confirmation that the product conforms to the defined user needs and intended uses

5. Applicable Laws, Regulations and Standards

  1. EU In-Vitro Diagnostic Medical Devices Directive 98/79/EC, Annex III CE Declaration
  2. ISO 13485 (2003)- Quality Systems - Medical Devices - Particular Requirements for the Application of ISO 9001
  3. CSA ISO - 13485 - Quality Systems Medical Devices Particular Requirements
  4. ISO 8402 - Quality Management & Quality Assurance - Vocabulary
  5. ISO 14971 - Second edition, 2007-03-01.  Medical Devices- Application of risk management to medical devices
  6. Title 21 CFR (800 - 1299) Food & Drugs
  7. Title 21 CFR 82.30 – Design Controls
  8. SOR/98-282 - Medical Devices Regulations, Canada
  9. GAMP 4, Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems
  10. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices  - http://www.fda.gov/cdrh/ode/guidance/337.html