Quality Vision Services


Compliance Service for US-Customers

Customers in the medical device manufacturing industry are bound by stringent regulatory requirements.   In particular, 21CFR Part 820.5b states:

“Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.”

To assist customers who are bound by this requirement, the following repository of information is provided:

PART 1: Changes to Service

DateDescription of ChangeReason for the Change
April 2017Enable use of electronic signatures and email read-receipts for customer service reportsModernize document management processes for QVS customers.

PART 2: Changes to Software

DateDescription of ChangeReason for the ChangeProducts Affected
April 2017Update definition of Sphericity form toleranceClarify the specification definitionMeasureMind3D - 16.1.82

Part 3: Changes to Hardware

DateDescription of ChangeReason for the ChangeProducts Affected
April 2017Introduction of New Product Feature - ECN28937Provides 100mm Field Of View (FOV) with single mag opticsSNAPTM
April 2017Adds an ambient light filter to improve performance of automatic ID software algorithms - ECN 28905Improve automatic ID performanceSNAPTM
April 2017Adds an Accucentric shutter to enable use of ambient light filter while maintaining Accucentric function - ECN 29065Improve performanceSNAPTM
April 2017Adds the use of a digital camera with GigE interface in place of a digital camera with Firewire interface - ECN 28911Improve video capture performanceZip and Zip-Advance product lines
April 2017Adds an optional ball screw driven X and Y axis stage in place of a rod drive - ECN 29050Improve performance for short travel movesZip and Zip-Advance product lines
April 2017Modifies the firmware and software for QVI scanning control - ECN 29072Improve tactile probing performanceQuest/Vantage, Flash/CNC, and Zip products with QVI Scanning Control
April 2017Modifies the thin film coating on standard front lens of Telecentric zoom systems by narrowing the wavelength band for specified reflectance values - ECN 29082Improve manufacturabilityQuest/Vantage
April 2017Modifies diffuser specification in the substage illuminator to transmit more light - ECN 29106Improve illuminationZip, Zip Lite Products
April 2017Modifies scanning/touch probe mount - ECN 29123Improve accuracy and repeatabilityFlash/CNC with tactile scanning and touch probe

Questions regarding this program may be directed to (866) 815-6618 or via email at service@qvsi.com