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process improvement champion

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Regulatory Guidance

An Expert who can provide guidance to Companies and support the needs of attorneys.

Ainslie provides attorneys and companies with his knowledge of accepted standards of care in the medical device field.

Regulatory Guidance

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 EU Directives Guidance

  • 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 bio-compatibility 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

Patent Evaluation

  • Review prior art relative to patent in question.
  • Research US and foreign patents.
  • Investigate  competitive equipment and perform due diligence evaluation of tests and design.
  • Assist in the discovery process by participating in depositions.
  • Review patent office file wrapper.
  • Act as either expert or fact witness.
  • Search and review publications relative to technology in question.
  • Provide an opinion of the technical aspects of the patent.