The essential step to a device launch
Consulting services for navigating medical device and diagnostic regulations.
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SERVICES

What we do

The MedTech industry is continuously evolving with new technologies and legislation. Innovation and regulatory advancements drive intense competition, pushing for faster, more effective treatments and diagnostics. Whether you're developing a medical device, drug delivery system, or In Vitro Diagnostic (IVD), we can assist you throughout the entire lifecycle — from design to post-market surveillance — to overcome regulatory challenges and deliver impactful products to patients and healthcare providers.

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About

Who we are

ReguLogix Consulting Ltd is your trusted partner in navigating the intricate landscape of medical devices and diagnostic regulation. We specialise in providing expert guidance to help you succeed in global markets by manoeuvring through evolving regulations and technological advancements.

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What we are best at

Our Services

Quality Assurance
Ensuring your products meet the highest standards of quality and compliance
Regulatory Affairs
Navigating complex regulatory requirements for market approvals
MedTech Due Diligence
Conducting thorough assessments to support strategic decisions
Documentation & Process Improvement
Enhancing efficiency and compliance through streamlined processes
Person Responsible for Regulatory Compliance (PRRC)
Providing PRRC services to meet EU MDR/IVDR requirements
UK Responsible Person
We are MHRA registered so that you can ensure compliance when entering the UK market
Training & Education
Equipping your team with essential regulatory knowledge and skills

Get in Touch with Us

Discover the flexible ways you can engage with our services based on your company's specific requirements. 
We offer the following options, which can be customised to align perfectly with your business needs:

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