regulatory consulting

Outsourced Quality Support

Outsourced quality and regulatory management is one of the most common practice when it comes to medical device industry. The quality assurance & regulatory affairs functions can be very complex to manage for different products. This is why medical device manufacturers look for outsourced quality support to manage operations and regulatory practices.

There are several things that medical device manufacturers need to understand at the primary stage of their product life cycle like product filings, regulatory pathway, manufactureing setup, as well as quality management systems creation.

You can check our QMS setup and implementation services here

Apart from the QMS setup and remediation, we offer several other services including:

Strategic leadership and management of the QA/RA functional areas
Staff transitions or augmentation
Special projects lacking internal bandwidth
Early stage companies looking for strategic insights for QA/RA.

8563 +

Saticfied Custimer

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Experience Team

Additional quality support services include

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.

Compliance Assurance

Stay compliant with industry regulations and standards.


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!

Looking for someone who can assist you

to build a compliant quality management system for your medical device company

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