Team Elexes 
Elexes Team 
UK CA Marking Consultant for Medical Devices
We at Elexes have a team who expertise in helping medical device manufactueres and companies get through the UKCA marking process successful. We have helped several companies bring their innovative medical devices into Great Britain including England, Scotland, and Wales.
What is UKCA Marking for Medical Devices?
If you wish to market your product in Great Britain, it is mandatory for your device to comply with UK MDR 2002 under UKCA (United Kingdom Conformity Assessment). These regulatory requirements are put enforced upon medical device companies to ensure the safety and efficacy of the medical device.
EU IVDR Regulations | Elexes’ Compliance Services
UKCA marking is required for the following:
⦿ Medical device manufacturers in the UK.
⦿ Distributors of medical devices in the UK.
⦿ Importers of medical devices into the UK.
Whether you’re a local manufacturer or an international supplier, meeting UKCA marking requirements is crucial for placing your product in the UK market.
Key Requirements for UKCA Marking
To place your medical device on the Great Britain market, you need to:
Obtain the UKCA Mark
This ensures your product meets UK regulatory standards and is safe to be marketed.
Register with MHRA
It is mandatory for all devices to be registered with the Medicines and Healthcare Products Regulatory Agency.
Appoint a UK Responsible Person (UKRP)
If you are based outside the UK, a UKRP is mandatory for you to market the product in the UK.
Classify Your Device
Determine your device's classification (Class I, IIa, IIb, or III).
How do Elexes Help?
Steps we follow to help you get UKCA Marking
Identify Applicable Directives and Standards
We help you determine the UK MDR regulations and standards relevant to your medical device.
Verify Prerequisites
Our experts make sure that all preconditions, including device classification and applicable guidelines, are met.
Conduct Safety and Performance Testing (If Required)
We also perform pre-clinical, safety, and performance investigations to confirm device compliance.
Compile Technical Documentation
Our experts help your team prepare a comprehensive technical file, including device specifications, risk assessments, and clinical data.
Submit to the UK Conformity Assessment Body (UK CAB)
We also help you share the technical documentation with the UK CAB for review and assessment.
Onsite Inspection and Technical File Review
Our experts will undergo an onsite inspection and evaluation of your technical files to verify compliance.
Our Expertise
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
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Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
A Trusted Team of Consultants
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Local Language
Auditor
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Why Choose Elexes?
Expertise
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
Local Regulatory Certification
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
Confidentiality
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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Clients Testimonials
Amazing Feedback Say About Services
Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
“
Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
“
Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
“
Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
“
Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
“
Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
“
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