Elexes Team 
Team Elexes 
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.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well within the boundaries of regulations but also speed up the entire approval process. Some of these services are -
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
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.
- Strategic leadership and management of the QA/RA functional area
- Staff transitions or augmentation
- Special projects lacking internal bandwidth
- Early stage companies looking for strategic insights for QA/RA
8563 +
Saticfied Custimer
263 +
Experience Team
Additional quality support services include
- Medical device single audit program (MDSAP) readiness audit
- Risk management (ISO 14971)
- Document control system implementation and remediation
- quality system implementation
- Quality system remediation
- ISO 13485:2016
- 21 CFR part 820
- Quality due diligence
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.
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!
Looking for someone who can assist you
to build a compliant quality management system for your medical device company
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.
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
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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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.
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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.
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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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