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Your Gateway to the EU Market Starts with CE Marking
CE Marking Consultants for Medical & IVD Devices
Elexes provides end-to-end CE Marking consulting services to help you meet EU MDR and IVDR requirements seamlessly. Whether you manufacture medical devices, IVDs, or combination products, our CE Marking consultants assist you with regulatory strategy, technical documentation, conformity assessments, and notified body interactions.
Ready to obtain CE certification without stress?
Let’s make your device EU-ready.
What is CE Marking and Why it Matters?
CE marking is your product's passport to the European Economic Area (EEA). It's not just a logo, it's a declaration of safety, compliance, and quality. Here’s what it means for your business:
Legal Requirement for Market Access
All medical and in-vitro diagnostic devices sold in the EU must comply with EU MDR or IVDR. CE marking confirms this compliance.
Boosts Credibility & User Confidence
Products with CE marks are seen as safe, reliable, and high-quality, leading to faster adoption in hospitals and clinics.
Involves Complex Compliance Steps
From GSPR mapping and risk analysis to notified body reviews, CE marking requires precise documentation and strategic execution.
How Elexes CE Marking Consultants Can Help
⦿ Regulatory Strategy Development: Device classification, roadmap, and compliance path.
⦿ Technical File Creation: GSPR checklist, risk management (ISO 14971), usability, clinical data.
⦿ IVDR or MDR Gap Assessments: Evaluate existing files and remediate gaps.
⦿ Notified Body Liaison: Submission support, Q&A responses, and audit prep.
⦿ Labeling & UDI Compliance: Review and develop EU-compliant labels and instructions.
⦿ Authorized Representative (EC REP) support: Representation for non-EU manufacturers.
Also explore our EU MDR Consultant and IVD Regulatory Consulting services.
End-to-End Support Across CE Marking Lifecycle
Pre-Market Strategy & Planning
⦿ Regulatory pathway analysis
⦿ Clinical evaluation planning
⦿ Classification confirmation
Documentation & Submission
⦿ Technical file preparation services
⦿ Design dossier review
⦿ Annex-specific documentation (Annex II, III)
Post-Market Surveillance & Vigilance
⦿ PMS and PSUR planning
⦿ Vigilance reporting systems
⦿ CAPA planning & implementation
Trusted By Global Manufacturers
We’ve helped startups and multinational companies across the globe secure CE marks for diverse products, from Class I reusable surgical tools to Class III implants and cutting-edge IVD platforms.
💡 With our CE certification consultants, you don’t just check boxes, you enter the market confidently.
Understand the CE Marking Journey
Let’s Get Your Device CE Certified!
It’s not just about getting a CE mark; it’s about staying compliant, competitive, and confident. Partner with Elexes to take the complexity out of compliance.
FAQs
Frequently Asked Questions!
CE marking for medical devices is a certification that indicates a device meets the health, safety, and environmental protection standards required in the European Economic Area.
Yes, especially for Class II and III devices or IVDs. A CE Marking consultant helps navigate EU MDR/IVDR requirements, technical files, and notified body submissions.
It can take 6–12 months depending on device classification, documentation readiness, and notified body timelines.
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!
So, if you are looking for a consultancy with deep expertise, experience, and established relationships with regulatory authorities, which can significantly enhance a company's regulatory journey and increase the likelihood of successful product registration and market access, all you have to do is
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 About Our 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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