California Comprehensive Compliance Program

Effective January 1, 2016, to the best of our knowledge, EndoShape Inc. (“EndoShape”) is in all material respects in compliance

with a Comprehensive Compliance Program (“CCP”) that satisfies the requirements of California Health and Safety Code §§

119400-119402, based on our good faith understanding of the statutory provisions as they may apply to a medical device manufacturer operating in California. 

EndoShape has modeled its CCP on The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”), which is applicable to the medical device industry and is similar to the PhRMA Code, which is consistent with the Department of

Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers

(“HHS-OIG Guidance”).

In addition to our CCP, EndoShape has established an annual spending limit for certain promotional activities directed toward healthcare professionals practicing in California, which is $500 per year for each applicable California healthcare professional. The

Limit applies to gifts, promotional materials, and other items or activities that are provided to an individual California healthcare professional but does not include work related remuneration.  
EndoShape is committed to the highest standards of ethical and legal conduct. We have developed a CCP that is reasonably

designed to prevent and detect violations, and includes the following:

  1. ​Written Standards. This includes a Code of Conduct and Ethics as well as a Compliance Policy.
  2.  Leadership and Structure. We have established a Compliance Officer and Compliance Committee for effective oversight of
    the CCP.

  3. Training and Education. We assure that all employees understand and agree to abide by the written standards in our Code
    of Conduct and Ethics and Compliance Policy, including those employees who regularly interact with healthcare

  4. Lines of Communication. We have adopted confidentiality and non-retaliation policies as well as mechanisms to facilitate anonymous reporting.
  5. Auditing and Monitoring. Our CCP includes ongoing efforts to monitor, audit, and assess compliance.
  6. Enforcement. EndoShape will consistently investigate and appropriately respond to violations.
  7. Corrective Action. EndoShape will take appropriate corrective action to prevent violations from recurring.

To obtain a print version of our CCP or this declaration, please call Customer Support at 1-844-870-5070

​         For more information, please contact us.

Statement of Compliance to California Compliance Laws