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One Two Medical
Home
Our Services
  • Services
  • IR IC Products Ireland
  • Med Device Distribution
  • Medical Device Consulting
Products
  • GRIP TT
  • Arm Positioning Device
  • Radial Solution
  • TruBrite
  • Catheter Wire Holder
  • Radiation Protect Shields
  • Steradian Shield
  • Mind Peace & Head Peace
  • Neptune
  • E-Neptune
  • Medical Arm Holder
  • Comfort Halo
  • Radial Arm Board
  • Radial Access Sleeves
  • Medical Devices UK
About Us
Contact Us
Blog
More
  • Home
  • Our Services
    • Services
    • IR IC Products Ireland
    • Med Device Distribution
    • Medical Device Consulting
  • Products
    • GRIP TT
    • Arm Positioning Device
    • Radial Solution
    • TruBrite
    • Catheter Wire Holder
    • Radiation Protect Shields
    • Steradian Shield
    • Mind Peace & Head Peace
    • Neptune
    • E-Neptune
    • Medical Arm Holder
    • Comfort Halo
    • Radial Arm Board
    • Radial Access Sleeves
    • Medical Devices UK
  • About Us
  • Contact Us
  • Blog
  • Home
  • Our Services
    • Services
    • IR IC Products Ireland
    • Med Device Distribution
    • Medical Device Consulting
  • Products
    • GRIP TT
    • Arm Positioning Device
    • Radial Solution
    • TruBrite
    • Catheter Wire Holder
    • Radiation Protect Shields
    • Steradian Shield
    • Mind Peace & Head Peace
    • Neptune
    • E-Neptune
    • Medical Arm Holder
    • Comfort Halo
    • Radial Arm Board
    • Radial Access Sleeves
    • Medical Devices UK
  • About Us
  • Contact Us
  • Blog

Medical Device Consultancy in UK

OneTwo Medical is a UK-based consultancy firm with over 13 years of sales and leadership experience in the MedTech industry. We specialise in sectors such as interventional radiology, interventional cardiology, urology, breast surgery, plastic surgery, and general surgery.


Our strengths include:

• A strong, diverse network and relationships

• Project and team management expertise

• A proven track record in new business setup and sustained growth


We ensure your products comply with UK regulatory standards, providing flexible solutions to help launch, protect, and grow your medical device enterprises, introducing innovative solutions that enhance patient and clinician health. 


Contact us today to learn how we can support your business goals.

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Meet Thanuj Tevar: Your Expert Consultant

 Thanuj Tevar offers over 13 years of experience in sales and leadership across various medical fields, including interventional radiology, cardiology, urology, and surgery. With degrees in Biomedical Science from Lancaster University and an MBA from Open University, Thanuj has a strong academic foundation.


Previously, as country manager for GC Aesthetics, he excelled in driving sales growth. At OneTwo Medical, he successfully launched over 15 new accounts in the past six months.


As a seasoned medical device consultant, Thanuj excels in building strong networks and driving success in the medical device industry. 

Why Choose OneTwo Medical?

Post-Brexit, the UK regulatory framework has changed significantly. We have unparalleled expertise in UK-specific regulatory requirements, especially those governed by the Medicines and Healthcare products Regulatory Agency (MHRA). Our comprehensive knowledge ensures your products meet all necessary standards.

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Our Services

Regulatory Compliance

Quality Management Systems (QMS)

Quality Management Systems (QMS)

Compliance with UKCA marking requirements is essential for any medical device entering the UK market. We stay updated with regulatory changes, providing timely advice and support to maintain compliance and avoid costly delays.

Quality Management Systems (QMS)

Quality Management Systems (QMS)

Quality Management Systems (QMS)

We align your quality management systems with ISO 13485 standards, tailored for the UK market. Our expertise ensures your QMS meets regulatory expectations and enhances the overall quality and reliability of your products.

Clinical Evaluation and Evidence

Quality Management Systems (QMS)

Clinical Evaluation and Evidence

Compliance with UK-specific clinical trial regulations is essential for demonstrating the safety and efficacy of your medical devices. We guide you through the clinical evaluation process, helping you gather robust clinical evidence that meets UK market requirements.

Product Development Support

Product Development Support

Clinical Evaluation and Evidence

We provide detailed guidance on UK-specific design controls and conformity assessment procedures. Our support ensures your product development processes are compliant and efficient, from initial design to market launch.

Market Access Strategy

Product Development Support

Market Access Strategy

Entering the UK market requires a strategic approach. We assist in developing comprehensive market access strategies, including distributor selection and local market research. Our insights into the UK healthcare system help you position your products effectively and achieve successful market entry.

Contact Us

For more information or to discuss how OneTwo Medical can support your regulatory and market access needs, please contact our UK office or reach out to our local representatives. We are here to help you navigate the complexities of the UK medical device market.

Frequently Asked Questions

Post-Brexit, the UK introduced the UKCA marking, replacing the CE marking for most products. Understanding these changes is crucial for market entry.

We provide comprehensive guidance on UKCA marking, helping you navigate the regulatory process and ensure compliance with all necessary standards

ISO 13485 is the international standard for quality management systems in the medical device industry. Aligning with this standard demonstrates the quality and safety of your products. 

We guide you through the clinical evaluation process, ensuring your clinical trials and evidence meet UK-specific regulations and guidelines. 

Our market access strategies include thorough market research, distributor selection, and tailored approaches to position your products effectively within the UK healthcare system.

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OneTwo Medical

54a Church Road, Ashford, TW15 2TS, United Kingdom

Phone: 01925 387 121

Copyright © 2024 OneTwo Medical - All Rights Reserved.

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