NIDEK CO Production Software

WARN 09/06/96 NIDEK CO., LTD.

Our investigator determined that your firm manufactures sterile and non-sterile products which include ophthalmological, optometrical, semiconductor measurement equipment, and intra-ocular lense.

2. Failure to prepare and implement quality assurance procedures adequate to assure that a formally established and documented quality assurance program is performed. For example: a) The firm has no software quality assurance plan for software developed in-house for controlling YC-1400 and CV-12000 devices; b) There are no software requirements or design specifications; c) Testing of software changes is purely functional.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.