ARKA REGWRITING LTD

Your MDR Gold Standard Compliance Partner

Navigating the regulatory landscape for medical devices in the EU (MDR 2017/745) and UK (MDR 2022) doesn’t have to be daunting.

ARKA REGWRITING LTD delivers submission-ready, high-quality regulatory and design documentation combining clarity, compliance, and efficiency so your products reach the market faster and with confidence.

Why Choose ARKA?

  • End-to-end MDR expertise: From Class I to Class III medical devices

  • Comprehensive documentation: Technical Files, Design Dossiers, Clinical Evaluation Reports, Risk Management Files, Instructions for Use, Labeling/UDI compliance

  • Design lifecycle mastery: User Needs, Design Inputs, Design Reviews, Design Verification & Validation

  • Fast turnaround: Timely delivery to meet your submission deadlines

  • Competitive pricing: High-quality services tailored to your budget

  • Independent, client-focused consultancy adapting to your project’s unique requirements

ARKA the gold standard in regulatory writing. We deliver quality, clarity, and reliable results, helping you navigate EU and UK MDR submissions with confidence and control.

Expertise that Delivers Results

At ARKA, we understand that deep therapeutic expertise is a key driver of successful scientific, regulatory, and commercial outcomes. That’s why we assemble dedicated project teams with direct experience in your specific product area. Our experts know the intricacies of your medical device, offering best practices, proven strategies, and tailored guidance to help you achieve your goals efficiently and confidently.

Our Company Expertise in Therapeutic Areas

Helping you meet EU and UK regulatory standards with confidence

Regulatory

Documentation aligned with current regulations

Clear, concise, and compliant writing

Regulatory support for CE and UK mark submissions

Technical
Consulting

About ARKA REGWRITING

We craft clear, compliant medical device documents that meet global regulatory standards with precision and care.

A focused consultant reviewing medical device documentation in a bright office.
A focused consultant reviewing medical device documentation in a bright office.
Our Approach
Our Expertise

Collaborative and practical, we bring real-world experience to ensure your documents are robust and ready.

Our Services

Clear, compliant medical device documentation tailored to your needs.

A consultant reviewing medical device documents with a client in a bright office.
A consultant reviewing medical device documents with a client in a bright office.
Close-up of hands typing on a laptop with regulatory guidelines on screen.
Close-up of hands typing on a laptop with regulatory guidelines on screen.
Regulatory

Guidance and writing that align with global medical device regulations.

Technical

Detailed, accurate technical documents crafted for clarity and compliance.

ARKA REGWRITING’s clear, precise documents made our regulatory submissions straightforward and stress-free.

★★★★★

© 2025. All rights reserved.