Regulatory Submissions

InVision Biomedical investigators have over 25 years of experience in performing scientific ISO and FDA quality testing for ophthalmic and other biomedical devices. InVision Biomedical's laboratories and analytical equipment are state-of-the-art. In addition, we have forged relationships with universities and other laboratories to bring our clients the most up-to-date and sophisticated analysis techniques.

Our scientific reports have formed the technical foundation of over 20 major regulatory filings worldwide. Our reports have been well- accepted in virtually all countries including the United States Food and Drug Administration (FDA). Our studies formed a significant basis for the regulatory submissions of two recently acquired Orange County start-ups that were. We continue to work with new start-ups as well as long-established multi-billion dollar biomedical companies to serve their testing needs.

"We have found over the years that every regulatory filing is unique and requires a team approach between sponsor and testing laboratory. We work closely with the sponsor to work out the specific regulatory analysis and evaluation strategy for the device. Often a risk analysis/FMEA is needed to guide the strategy and we have the experience to help a sponsor perform this analysis if needed."

~ Dr. Marie Dvorak Christ

The basis for our ophthalmic device testing services is the ANSI Z80 and ISO 11979 standards for intraocular lenses.

InVision Biomedical offers the full range of Physicochemical tests recommended in Paragraph 5 of ISO 11979-5:2006, Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility.

Studies - ISO 11979-5:2006 In Vitro Biocompatibility testing:

  1. Hydrolytic Stability (Annex C)
  2. Photostability Test (Annex D)
  3. Exhaustive Extraction Test (Annex A)
  4. Test for Leachables (Annex B)
  5. Nd-YAG Laser Exposure Test (Annex E)
  6. Evaluation of Insoluble Inorganics

Mechanical Testing - According to ISO 11979-3:2006, Ophthalmic implants — Intraocular lenses — Part 3:

InVision Biomedical works closely with each client on a customized basis with an overall Regulatory Submission Strategy:

  • First, we discuss the particular device, materials, and special requirements thoroughly with the client.
  • Next, we design a customized protocol for each study reflecting the inputs of the client.
  • Study samples are received and logged-in with custody carefully maintained throughout the entire study.
  • The studies are conducted in a timely fashion with careful attention to details especially "line-clearance" from other studies, sample handling, and overall cleanliness. Minimization of laboratory-borne and handling-related contaminants is essential particularly because of the high sensitivity of many of the analytical methods we typically employ.
  • Once the test data are collected and compiled a thorough report is assembled and presented to the client.
  • Reports and all raw data are archived at InVision Biomedical for future reference as needed.

Call us today to request more information on FDA and CE Ophthalmic Device Regulatory Testing

Contact Information

InVision Biomedical
16590 Aston
Irvine, CA 92606

Ph: (949) 872-2126
Fx: (949) 872-2754

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