Pro-Optics, LLC
1 extracted findings
FDA source excerpt, selected passage
Failure to document procedures for design and development, as required by ISO 13485:2016, Clause 7.3.1. Specifically, your firm failed to document procedures for design and development, including design and development: inputs, outputs, review, verification, validation, transfer, and control of changes for the Pro Optics Tight Top and Flip Top Contact Lens Cases. For example,
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to document procedures for design and development, as required by ISO 13485:2016, Clause 7.3.1. Specifically, your firm failed to document procedures for design and development, including design and development: inputs, outputs, review, verification, validation, transfer, and control of changes for the Pro Optics Tight Top and Flip Top Contact Lens Cases. For example,
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.