Your Global, End to End key MedTech Regulatory Parter

Intelligence Based, Tech-Empowered Regulatory Compliance Supporting Medical Device Lifecycle

Services We Offer

The framework for medical device regulations is swiftly evolving to ensure the safety and efficacy of products, keeping up with the rapid advancements in the industry. These regulations are complex and often not clear, notably in semi-regulated developing markets. Even in strictly regulated, established markets, guidelines are constantly revised to fulfil increasing demands. Artixio, with a global team of skilled regulatory professionals, regional insights and wealth of experience in effectively ensuing compliance of medical devices right from registration to post market maintenance helps manufacturers with integrated regulatory solutions.

Medical Device products supported:

Our vast services and broad range of experience spanning across product categories helping manufacturers, Contract Research and Manufacturing Organizations in global markets across North America, LATAM, APAC, EU, MENA and EUEA.

Active Implantable Medical Devices
Vascular
Mobile devices
SaMD
Combination Device
Diagnostics
Ophthalmology
Orthopedic

Integrated Regulatory Solutions for Medical Device

Regulatory Intelligence & Strategy
Submission Strategy
Authorized Representative Services
End to end Clinical Trial study support
Device Registration
Labeling Compliance
QMS Compliance
Post Approval Life Cycle Management
Ancillary Applications (Free Sales Certificate, Import Licenses etc)
Non-HA Approvals
Post-Market & Materiovigilance

Why Artixio?

FAQs

Which markets do you cover with your MedTech regulatory services?

We have our presence across North America, LATAM, APAC, EU, MENA and EUEA regions providing regulatory consulting and submission services.

How do you stay updated with the global regulatory changes?

Artixio has its own inhouse, AI enabled Regulatory Intelligence platform – QuriousRI, which tracks global regulations across different product categories and health authorities with professionally led impact assessment to ensure that we are compliant with varying regulations. Our platform was recognized at the CPHI Pharma Awards 2024 under innovations in regulatory affairs category.

Do you support on project basis work or also provide team members for specific duration?

We provide both project-based services and regulatory specialists with different backgrounds and skills on a retainer basis through our staff augmentation program. Our team members work directly with our clients as extended teams in over 30 countries, assisting with crucial product registration and lifecycle management projects.

How do you align with our company’s policies and procedures?

Artixio is ISO 9001 certified and our processes, standard operating procedures are developed in accordance with global regulatory standards and industry best practices for managing complex pharmaceutical regulatory affairs. Further, we are flexible to work with our clients’ SOPs and processes as an extension of their teams with necessary training. We have examples and case studies to demonstrate how seamlessly we continue to support our clients, including global top 10 pharma with their regulatory affairs operations in global markets. Artixio addresses these challenges by providing flexible, budget friendly and timely compliance solutions and regulatory affairs services using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.

What are the significant challenges faced by industry in managing global regulatory affairs for medical devices?

Managing global regulatory affairs for medical devices requires navigating varied and often inconsistent regulatory standards across different countries, which obstructs compliance efforts. The lack of standardisation in regulatory processes, coupled with resource limitations, makes it challenging for companies to manage these processes efficiently. Additionally, adapting to new and changing regulations, ensuring post-market compliance, and dealing with complex approval processes require continuous monitoring. Effective communication with regulatory authorities and stakeholders is also vital to address queries and expedite reviews. Artixio with his focus and comprehensive coverage helps pharma manufacturers stay ahead with the changes and implement timely interventions for compliance.