Finding our website is your first step to help with your regulatory compliance issue. MAK and Associates, LLC provides value and solutions to small to medium size Medical Device Manufacturers, Medical Device Importers, and Healthcare organizations.


  • You have little understanding of regulatory issues or the ramifications if there are problems.
  • You cannot afford a staff person for regulatory and quality.
  • You already have some regulatory or quality issues that threaten the business.


  • Regulatory and Quality Strategy and Planning.
  • Establishment and Product Registrations.
  • Regulatory Market Approvals.
  • Compliant Quality System.
  • Adverse Event Response.