MCRA’s healthcare compliance team has extensive experience assessing, developing and designing healthcare compliance programs for medical device companies.
Our Integrated Approach to Compliance Programs
MCRA’s healthcare compliance team has extensive experience assessing, developing and implementing healthcare compliance programs for organizations of every type and size. From startups through large corporations, MCRA provides a variety of services to keep your organization compliant with the myriad of complex laws and regulations that impact our industry.
Healthcare Compliance Programs must be evaluated periodically to assess their effectiveness. Lack of an effective Compliance Program creates risk and potential civil and criminal liability that no organization needs. Contact us today to see how MCRA can assist you in managing and mitigating all aspects of your enterprise compliance risk.
Our Approach to Medical Device Compliance Programs
- Strategic Compliance Plan & Process Development
- Code of Conduct, Policies and Procedures
- Healthcare Compliance Training & Education for Employees and Board of Directors
- Sanction and Exclusions Screening
- Conflict of Interest Management
- Strategic Integration of Compliance Into Daily Operations
Strategic Healthcare Compliance Plan & Process Development
MCRA understands what companies need to comply with current laws and regulations. At MCRA we closely follow legislative and regulatory development so we understand how they will impact your business. MCRA’s team has the expertise to anticipate, create, and implement the strategic compliance initiatives and operational services to support your organization's key business objectives to drive your success.
Compliance Policies and Procedures
Regulators, Boards of Directors, employees and customers require and expect healthcare organizations of every size and type to have compliance policies and procedures that support the detection, prevention, and remediation of non-compliant business activities. Well-drafted and fully implemented policies and procedures demonstrate an organization's commitment to ethical business practices. Creating and maintaining these programs is challenging for every manager.
MCRA can assist in the creation and implementation of required policies and procedures to help you quickly identify compliance issues and develop a corrective plan of action.
Healthcare Compliance Training and Education
MCRA provides employee training and education that covers federal healthcare compliance requirements. The specific training is tailored to your organization’s culture to make the time as meaningful as possible for each group of employee participants. We can also provide required training for your Sales Team and Board of Directors.
Conflict of Interest Management
Conflicts of interest often arise in healthcare, particularly with complex financial relationships and during research related activities. MCRA can assist in evaluating whether there is an actual, potential or perceived conflict of interest. If so, MCRA can provide a comprehensive management plan created to proactively address questions that may arise regarding an individual's objectivity, integrity or professional commitment as the result of a disclosed activity, relationship or financial interest.
Telephone Hotline Management
MCRA can assist in providing a federally required confidential disclosure program for your organization, including a toll-free telephone line and email service that allows employees to report compliance concerns. MCRA can also assist organizations with appropriate content to promote the hotline for company websites, newsletters and other communications to ensure employees are informed about this confidential resource.