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Medical Devices

Sandler, Travis & Rosenberg can assist clients with medical device compliance issues by providing the following services.

  • Counsel on all phases of the product development cycle, including pre-clinical activities, clinical trials, application process, product maturity and post-market environment, including guidance on risk management and regulatory strategies to help bring products to market as quickly as possible.
  • Preparation of pre-market applications (510(k)). Determination of appropriate device classification (class I, II or III) or existence of exemption status.
  • Identification of predicate devices for substantial equivalence determination.
  • Support in design processes and failure analysis, verification, or validation protocols in addition to required medical device reporting.
  • Counsel sponsors, public and private institutions, Institutional Review Boards, clinical research organizations, site management organizations and principal investigators on various issues involving clinical research.
  • Support in developing Federal Trade Commission-compliant advertising materials (print and Internet).
  • Counseling clients on good manufacturing practices, labeling and advertising matters, conducting product recalls, responding to warning letters and managing FDA inspections.
Gilbert Lee  Sandler
T: 305.894.1000
Founding Member
  • ST&R
Domenic J. Veneziano
T: 202-734-3939
Independent FDA Regulatory and Strategic Consultant
  • ST&R


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