Artixio

EU MDR Gap Assessment Services

Start your journey to EU MDR compliance with a clear, structured Gap Assessment.
Identify what’s missing — and what it takes to meet every requirement.

Procedures, Processes, and CE Technical Documentation EU MDR Gap Analysis

Artixio is aware that the new regulations from the European Commission, which are intended to enhance clinical safety and fair market access, may have depleted your current regulatory resources. Once the MDR goes into force in 2021, the businesses that are unable to completely implement these changes will be severely handicapped in the highly inventive and competitive medical device market.

Artixio’s team of regulatory experts performs gap analyses to help your firm move smoothly. Your team will be able to identify precisely which areas need to be changed at your company to comply with the new MDR with our assistance. With a focus on your policies, practises, and CE technical documentation, our gap analysis will look at the current state of your business’ regulatory affairs. It is crucial to conduct a thorough gap analysis because it will pay off strategically with your planned clinical efforts.

Our engagement is intended to better meet your specific needs after we finish your gap analysis. With the help of our individualised consulting services, we can create a strategy to close all of the regulatory gaps identified by our investigation. Your leadership will be able to accurately determine which aspects of the MDR transition can be handled internally and which components require outsourcing after analysing the findings with your team. Our clients frequently struggle to meet the new criteria without growing their own resources, which could result in regulatory shortcomings because of financial limitations. Because of this, it is crucial that your regulatory team takes the initiative to plan how you will respond to the changes in the MDR.

Our analysis of your compliance with EU MDR 2017/745 identifies the following gaps

Still Have Questions ?

Get expert answers tailored to your needs.

Specialized Regulatory Services
Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Product Registration
Investigation New Drug Application (IND)
New Drug Application (NDA)
Post Approval Lifecycle Maintenance
Artwork and Label Review
Ad Promo Review

Regulatory Services Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

European

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea

Tips & Articles

In Vitro Diagnostics: Meaning, Types And Benefits

In Vitro Diagnostics: Meaning,

The term “in vitro” is a Latin word that means “in glass”. Thus, from...

June 20, 2025
IVD Medical Devices Registration & Approval In India

IVD Medical Devices Registration

The in vitro diagnostic in India is regulated by the Central Drugs Standard Control...

June 17, 2025
Pharma Manufacturing Booms in Hidalgo, Mexico

Pharma Manufacturing Booms in

Once overlooked pharma hub in Mexico's Hidalgo region has gained importance with global market...

June 18, 2025