Ethics

The medical device industry has faced multiple challenges in recent years: product recalls and quality problems, reports about conflicts of interest and kickbacks, concerns about adverse events, and warnings of increased scrutiny from US and non-US regulatory and enforcement agencies.  Add to those issues the risks inherent in a globalized production model, including violations of laws such as the US’ Foreign Corrupt Practices Act and the UK’s Anti-Bribery Act.

Kaplan EduNeering has worked with medical device companies to achieve and maintain compliance with multiple layers of regulatory requirements and directives.  Our technologies, learning and communications resources, experience and subject matter expertise assure companies our medical device solutions are proven, effective and cost-efficient.  

Kaplan EduNeering is the exclusive online learning partner of AdvaMed. We were selected by the US FDA to design and operate the Office of Regulatory Affairs’ online university, ORA U, and continue to have an exclusive partnership with FDA through our Cooperative Research and Development Agreement.  That agreement provides our clients access to the same technology and curricula that FDA uses to train its inspectors around the world and that is now being used by other government agencies in the US and abroad to train inspectors and regulators.

We have helped medical device companies around the world comply with regulations and laws that are being enacted as part of a global anti-corruption effort.  Among the ethics compliance issues we address:

• Foreign Corrupt Practices Act;
• UK Anti-Bribery Act;
• US and State conflict of interest laws;
• Corporate Code of Conduct/Ethics (available in 30 languages);
• Code of Conduct/Ethics training for employees;
• Code of Conduct/Ethics training subcontractors or other relevant parties;
• Government contractor ethics training (US);
• AdvaMed Code of Conduct training, testing, validation and documentation;
• Specialized training in topics including grants and education; gifts, meals and refreshments, evaluation and demonstration of products, interactions with healthcare providers;
• Training and certification of sales representatives for access to healthcare facilities including hospitals,  clinics and research facilities;
• Discrimination and retaliation;
• Interactions with healthcare professionals training;
• Ethics Communication Coach, a subscription-based service providing learning and communications tools for use in corporate compliance initiatives including culture reinforcement, ethics training and corporate communications;
• All training is distributed, validated, tested and documented in audit-ready format.  Additional capabilities enable the rapid generation of individualized remedial training, quizzes, forms and questionnaires.