In God We Trust, All Others Must Provide Evidence

We are Global Regulatory and Quality Consulting services for Medical Device industry. Our approach is to design, implement and maintain custom-made integrated QMS models in compliance with the local and essential global regulations.

Why MDV-Solve

Why Choose MDV-Solve?

We are Global Regulatory and Quality Consulting services for Medical Device industry.

Our approach is to design, implement and maintain custom-made integrated QMS models in compliance with the local and essential global regulations.

With years of experience in the medical device industry, we provide comprehensive solutions tailored to your specific needs.

Read More About Us
About MDV-Solve

Our Services

We in MDV-Solve offer Regulatory and Quality Management System (QMS) consulting services. Our service includes creation, update, implementation, and maintenance, verification of effectiveness of the requested sub-systems to build up an integrated QMS, alongside training and auditing.

The New EU Medical Device Regulation (MDR)

The New EU Medical Device Regulation (MDR)

Comprehensive guidance on EU MDR compliance requirements for medical device manufacturers.

+ Learn More
MDSAP Program

MDSAP Program

The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit.

+ Learn More
Quality System under EN ISO 13485, US FDA QSR - GMP

Quality System under EN ISO 13485, US FDA QSR - GMP

The purpose is to enable you to establish and implement an effective tailored QMS system including GMP requirements.

+ Learn More
Design Control Under EN ISO 13485 & 21 CFR PART 820

Design Control Under EN ISO 13485 & 21 CFR PART 820

Establish and implement a system for design controls for various classes of medical devices.

+ Learn More
The Literature Route for Clinical Evaluations

The Literature Route for Clinical Evaluations

Practical solution on evaluation of clinical data for CE marking medical devices and local regulation.

+ Learn More
The New EU IVD Regulation (IVDR)

The New EU IVD Regulation (IVDR)

The In Vitro Diagnostic Regulation stipulates all requirements IVD manufacturers must comply with.

+ Learn More
Application of Risk Management to Medical Devices

Application of Risk Management to Medical Devices

Integration of a risk management system into your existing quality management system.

+ Learn More
Process Validation Including Software

Process Validation Including Software

Implementation of process validation system including IQ, OQ, and PQ qualifications.

+ Learn More
Post-Market Surveillance and Vigilance

Post-Market Surveillance and Vigilance

Establishment and implementation of PMS to review experience gained from devices in the post-production phase.

+ Learn More
Good Manufacturing Practice (cGMP)

Good Manufacturing Practice (cGMP)

Establish and implement an effective tailored cGMP system in line with requirements.

+ Learn More
Clinical Evidence — IVDR

Clinical Evidence — IVDR

Under IVDR Article 56 - clinical data and performance evaluation results for device safety assessment.

+ Learn More
AI Complaint Handling System

AI Complaint Handling System

Advanced AI-powered system for efficient complaint handling and regulatory compliance.

+ Learn More

Contact Us

Address

Steenweg 3, BUS 402, 3540 Herk-de-Stad, Belgium

Send Us a Message

Contact Us

We typically reply within a few hours

👋 Hi there! How can we help you today?

Fill out the form below and we'll get back to you as soon as possible.