Regulatory Consulting

Navigating Regulatory Complexity with Ease and Expertise

• Conduct a gap assessment aligned with specific regulations.
• Introduce your Software as a Medical Device (SaMD) or digital health products to new markets.
  • Prepare for submission.
  • Review essential documentation.
• Establish and manage post-market compliance activities.

QMS Consulting

Customize Your QMS to Meet Your Company’s Unique Needs and Ensure Compliance

MediqWise is here to assist you in:

• Providing comprehensive documentation, implementation, and training services.
• Preparing for audits with thorough and expert guidance.
• Establishing new practices or enhancing existing ones for improved quality management.
• Offering outsourced Quality Manager services, available for ad-hoc, interim, or long-term engagements.