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…

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.

regulatory consulting

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.

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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.

Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Why choose

Elexes for medical device regulatory & compliance services?

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!

Associated Regulatory Authorities.

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