Alan Broadwin — Ainslie

Increase your ability to prosecute or defend your case with device expertise.

Documentation Review

• Review reports and deposition testimony.
• Research pertinent publications
• Review company Quality Manual and procedures.
• Review evidence of Design Control processes.
• Review clinical trial reports.

 FDA QSR/GMP Gap Analysis

•  Compare company system to current FDA Quality System Requirements.
• Compare company system to FDA historical requirements.
• Compare company system to ISO and other system requirements.

 Records Data Review

•  Evaluate device specific documents.
• Review process validation reports.
• Review evidence of Sterility tests.
• Review performance of biocompatability tests.

Deposition Trial Testimony

•  Develop the rationale for an opinion.
• Compare the company system and performance with the standard of care expected.
• Provide attorney with written opinion if requested with documents upon which the opinion relies.