Core Consulting Services

  • Regulatory Compliance Consulting

Strategy and guidance for meeting complex medical device regulations.

  • QMS Design & Implementation

Build quality systems tailored to operational goals and certification pathways.

  • Certification & Audit Readiness

Support for internal/external audits and preparation for ISO or regulatory certifications.

  • Financial Planning for Compliance

Align compliance actions with budget, ROI goals, and sustainable resource allocation.

  • Supplier & Procurement Evaluation

Ensure vendors and devices meet safety, regulatory, and ethical standards.

  • Risk & Continuity Management

Develop systems to anticipate and manage operational and regulatory disruptions.

  • ICT Integration for Compliance

Apply digital tools to improve traceability, data integrity, and monitoring efficiency.

  • ESG & CSR Advisory

Integrate responsible business practices aligned with sustainability and reputational goals.

Each service is tailored to meet industry-specific challenges, from global standards and traceability to financial risk and long-term performance.