MAK and Associates engages its clients in a proven process which gets to the root of your issues and reaches the heart of the solution.

We partner with you to develop a statement of work which delivers a compliant, realistic, and affordable service set. After the SOW is agreed upon, a project team is selected which includes consultants who have the expertise to solve your issues. A sample of our compliance expertise includes:

Submissions

  • Regulatory Strategies
  • Device Classifications
  • Registrations and Licensing
  • 510(k), CE Marking, design controls
  • Safety Certifications

Implementations

  • Quality Systems Registrations
  • Computer Systems Validation

Compliance

  • GAP Assessments
  • FDA GMP
  • EC MDD
  • HHS HIPAA & Meaningful Use

Mock Inspections

  • Adverse Event Response
  • Device Recalls and Corrections