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Elexes Team 
Compliance Assurance
Stay compliant with industry regulations and standards.
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Achieve regulatory success with Elexes, all within your budget.
EU MDR Consultants
A perfect team of professionals who can support you in registering your medical device safely in Europe. At Elexes, we help you -
⦿ Understand the latest requirements as per EU MDR/IVDR
⦿ Be fully transparent about the regulatory requirements
⦿ Perform pre-market control as well as clinical evaluation
⦿ Create and review technical documentation required as per EU MDR/IVDR
EU MDR Consultants
Elexes has a team of professional MDR experts who specialize in supporting medical device manufacturers in bringing new medical devices to the European market. As per the new European Medical Device Regulations (EU MDR) 2017/745, medical device manufacturers must comply with several regulatory requirements if they wish to launch their products.
Some key provisions of the EU MDR 217/745 include:
⦿ Classification of medical devices
⦿ Conformity assessment
⦿ Post-market surveillance
⦿ Unique device identification (UDI)
⦿ Clinical evidence
⦿ Notified bodies
⦿ Traceability
When it comes to bringing medical devices to the European market, compliance with EU MDR is a necessity, and non-compliance will cause direct rejection of the device, product recalls, suspension of CE certificat,e and more…
Our EU MDR Services
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Who needs EU MDR?
Companies developing, manufacturing, or distributing medical devices for CE marking or export to Europe can benefit from our MDR consulting services, whether startups, SMEs, or large corporations.
Manufacturers without experienced staff for technical file preparation or CER review should consider engaging MDR consultants. First-time applicants especially can streamline processes, expedite documentation, and improve their chances of achieving compliance and certification with expert guidance.
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.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
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.
“
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.
“
Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
“
Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
“
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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