MCRA Compliance

MCRA’s Compliance Services are designed to help a growing healthcare organisation or medical device company recognise the importance of an effective corporate compliance programme in today’s complex legal and regulatory environment.

The healthcare compliance team at MCRA has extensive experience assessing, developing, and implementing healthcare compliance programmes for organisations of all sizes. MCRA provides a variety of services to keep your organisation, from startups to large corporations, in compliance with the plethora of complex laws and regulations that impact our industry.

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Our Process

MCRA Compliance

MCRA’s Compliance Services are designed to help a growing healthcare organisation or medical device company recognise the importance of an effective corporate compliance programme in today’s complex legal and regulatory environment.

The healthcare compliance team at MCRA has extensive experience assessing, developing, and implementing healthcare compliance programmes for organisations of all sizes. MCRA provides a variety of services to keep your organisation, from startups to large corporations, in compliance with the plethora of complex laws and regulations that impact our industry.

To determine the effectiveness of healthcare compliance programmes, they must be evaluated on a regular basis. A lack of an effective compliance programme creates risk as well as potential civil and criminal liability, neither of which is desirable for any organisation. Contact us today to learn how MCRA can assist you in managing and mitigating all aspects of your enterprise compliance risk.

MCRA is a privately held, highly specialised consulting firm and Clinical Research Organization (CRO) serving the global medical device industry. MCRA is a team of top strategists committed to integrating regulatory, clinical, reimbursement, quality assurance, and healthcare compliance strategies for our clients. Founded in 2003, the firm’s superior knowledge base, global surgeon relationships, and highly experienced management team provide its clients with “best-in-class” service. MCRA emphasises its expertise in guiding technologies from the conceptual pre-clinical stage to market approval, working with companies at all stages of development and throughout the technology life cycle.

Our mission is to be the most experienced musculoskeletal strategic advisory team, guiding our clients’ products quickly and successfully through the regulatory, clinical research, reimbursement, compliance, and quality assurance processes, creating maximum value for their shareholders. Our vision is to be the leading medical device advisory firm in the market. MCRA’s vision is to provide the same leading quality of services throughout the medical device industry as it is recognised as the market leading provider of regulatory, reimbursement, clinical research, compliance, quality assurance, and hospital services.

  • KYC of directors
  • CIBIL record of directors
  • Address proof and PAN card of the company
  • GST registration certificate
  • Filed GST returns
  • Books of audited financials
  • Bank statement of the past 12 months
The healthcare industry is highly regulated and difficult to navigate legally. It is best to hire (or contract with) someone who specialises in healthcare compliance to help you understand which regulations your entity must follow, as well as develop an internal compliance infrastructure and training. Check that this professional has relevant experience, is properly certified, and is not on the Office of Inspector General's (OIG) list of excluded individuals.
No. An investigation or audit will not tolerate a lack of knowledge. It is your responsibility, as a healthcare entity or individual, to keep up with and comply with state and federal regulations. State or federal officials will believe you should have known better.
Employees in various healthcare roles, such as coding and billing, should receive appropriate training (HIPAA, HITECH, etc.) upon hire and at least annually thereafter. Employees should be trained whenever existing regulations change or are updated, as well as when new regulations are implemented.

Our Strategy for Compliance Programs

  • Development of a Strategic Compliance Plan and Processes
  • Conduct code, policies, and procedures
  • Healthcare Compliance Education and Training for Employees and the Board of Directors
    Exclusions and Sanctions Screening
  • Management of Conflicts of Interest
  • Strategic Compliance Integration Into Daily Operations