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Medical Device Regulatory Affairs Consulting Services
Intelligence Based Regulatory Affairs Solutions for medical devices approvals, technical documentation, and compliance. Trusted support for device companies worldwide.

Services We Offer
Medical device regulations are changing fast. Some markets have detailed rules, others are still catching up. In many regions, the process is confusing and often unclear. Even in countries with strict systems, authorities keep updating their guidelines to match industry growth. That’s where Artixio comes in. As a MedTech global regulatory affairs partner, we help medical device manufacturers handle everything—from registration to post-market tasks—without the usual delays or confusion. Our team understands the local context and knows how to get things done.
Regulatory Affairs Strategies For Medical Devices
Medical Device products supported:
Our support in the medical device regulatory affairs approval process, combined with broad experience across product categories, helps manufacturers and Contract Research and Manufacturing Organizations succeed in global markets—including North America, LATAM, APAC, EU, MENA, and EAEU.
- 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?
How do you stay updated with the global regulatory changes?
Do you support on project basis work or also provide team members for specific duration?
How do you align with our company’s policies and procedures?
What are the significant challenges faced by industry in managing global regulatory affairs for medical devices?
Still Have Questions ?
Specialized Regulatory Affairs Services Across Multiple Industries
Expert Regulatory Services To Streamline Compliance

Regulatory Intelligence & Strategy

Medical & Technical Writing

Publishing & Submission






Regulatory Affairs Across Multiple Countries

India

Singapore

Mexico

Brazil

Vietnam

Malaysia

Argentina

Colombia

Taiwan

China

Europe

Thailand

Indonesia

Philippines

USA

Japan

Qatar

South Korea
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