Consulting
Tailored technical-regulatory support—practical, strategic and built around your device life cycle.
Comprehensive, flexible, results-driven support
MediQuasar supports organisations throughout the regulatory journey, from initial feasibility assessment to operational consulting delivered on-site or remotely.
The aim is to turn regulatory complexity into informed decisions, clear processes and practical solutions—ensuring safety, compliance and robust regulatory governance.
Every engagement is shaped around the organisation’s real needs, integrating with in-house teams and providing immediately actionable support.
Our three consulting formats
A preliminary technical and regulatory review of products, projects or devices to evaluate classification, risks, potential issues and market potential.
Operational support delivered directly at your premises: manufacturing processes, quality systems, risk management, internal procedures and documentation review.
Targeted, flexible support delivered either on-site or remotely, without disrupting day-to-day operations.
CONSULTING SERVICES – DETAILS
Feasibility assessment
This service provides an initial review of devices, projects or product lines to determine technical and regulatory feasibility. It identifies risks, documentation gaps, mandatory requirements and potential market placement strategies.
- Classification and requirements assessment
- Identification of regulatory issues
- Market opportunity assessment
- Practical roadmap with steps and priorities
On-site consulting
Practical on-the-ground support in close collaboration with in-house teams. Ideal for organisations requiring immediate assistance with documentation, manufacturing processes or quality systems.
- Review of business processes and workflows
- Optimisation of procedures and risk management
- Practical alignment with MDR/IVDR requirements
- On-site staff training
Flexible remote consulting
A flexible service designed for specific needs or document/regulatory reviews that do not require on-site presence. It ensures rapid response and operational continuity.
- Review of technical documentation and key records
- Support for regulatory updates and procedures
- Verification of compliance with ISO/MDR/IVDR
- Targeted staff training
Benefits of our consulting approach
Practical, implementable and documented solutions.
Direct collaboration without duplication.
Services can be modular and scaled to your needs.
Ongoing alignment with regulations, standards and new guidance.
Do you need targeted regulatory consulting?
We’re ready to support you with practical delivery, strategic guidance and a fully tailored approach.
MediQuasar s.r.l.
Via Vittorio Veneto, 11,
41032 Cavezzo MO, Italia
Phone. +39 393 2859 8580
Mail info@mediquasar.it
Vat no. 04162970364