A Professional Support for No Delays or Compliance Gaps

Data Integrity & GMP

It is vital that medical device companies maintain proper data integrity during the manufacturing process of any medical device. Our experts at Elexes Medical device Consulting will help you adhere to all the standards issued by the global regulatory bodies and will help you stay within the cGMP while preserving your data’s integrity.

With the set of services we offer and the consulting process we follow, you can rest assured that all your regulatory regulations and compliance issues are addressed professionally - including cGMP manufacturing compliance and medical device’s data integrity.

Our cGMP & Data Integrity Training Services

We, at Elexes, one of the most trusted medical device consulting companies have a proper and well-established training module that ensures proper compliance to both cGMP and data integrity regulations set by global regulatory bodies. 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.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Associated Regulatory Authorities.

Our cGMP Training Program Includes

8563 +

Saticfied Custimer

263 +

Experience Team

Our Services

Market Feedback Analysis

Market Feedback Analysis

We analyze customer feedback and market trends to identify potential product improvements…

Read More
Regulatory Updates and Compliance

Regulatory Updates and Compliance

Our experts stay up-to-date with evolving cosmetic regulations and ensure your products…

Read More
Post-Market Surveillance Reporting

Post-Market Surveillance Reporting

Our team helps in preparing and submitting necessary post-market surveillance reports to…

Read More
Product Quality Monitoring

Product Quality Monitoring

We provide guidance on establishing quality control processes to monitor the consistency…

Read More
Corrective and Preventive Actions (CAPA)

Corrective and Preventive Actions (CAPA)

In case of any product-related issues or non-compliance, we help you plan…

Read More
Customized Post-Market Surveillance Plans

Customized Post-Market Surveillance Plans

We create tailored post-market surveillance plans to meet your specific product and…

Read More
Product Recalls and Withdrawals

Product Recalls and Withdrawals

If necessary, we assist in planning and executing product recalls or withdrawals…

Read More

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.

img
img

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.

Regulatory & Quality Compliance Consutng

Why Choose Us?

We help manufacturers be compliant to all the regulatory standards and quality standards.

Stay compliant with industry regulations and standards.

Achieve regulatory success with Elexes, all within your budget.

Experience timely results with our efficient services.

We offer 100% confidentiality understanding how critical the data is for you.

img
img
Parul Chansoria
Founder
We help companies streamline their entire regulatory & compliance processes.

Looking for someone who can assist you

with regulatory compliance?

Clients Testimonials

Amazing Feedback Say About Services

Popular Clients

We’ve 200+ Global Premium Clients

Looking For Regulatory Assistance?

Let's Talk How We Can Help You?

Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img
Please enable JavaScript in your browser to complete this form.
Name
img