Team Elexes 
Compliance Assurance
Stay compliant with industry regulations and standards.
Cost-effective
Achieve regulatory success with Elexes, all within your budget.
Regulatory | Quality | Compliance
A Trusted Medical Device Regulatory Consulting Company
Elexes has been a trusted name among the best medical device regulatory consulting company. Over the years, we have helped top medical device companies to get their medical devices approved in the desired markets. With a team of experienced medical device regulatory consultants, we have managed to become the go-to agency for many medical device companies all around the globe for several services like regulatory approvals, regulatory due diligence, clinical trial documentation, QMS system support, and more...
Our expertise in providing end-to-end solutions from the Product development stage, regulatory approvals to product launch & beyond (Post-market surveillance) makes us stand out among other medical device regulatory and quality consulting agencies across the world.
Along with being known for FDA medical device regulatory consulting, we are also known to help companies get approval across different regulatory bodies like HealthCanada, EMA, HSA, MHRA, and more...
Need Help?
Associated Regulatory Submissions
250 +
Successful Projects
200 +
Product types
90 %
Audits cleared
100 +
Global Clients
Get All Under One Roof
Our Expertise
Compliance Training & Inspection Readiness
QMS compliance training, regulatory compliance training, QMS record generation training, Training sessions for ISO 13485, MDSAP, IEC 62304, ISO 14971, HIPAA compliance training, to GCP, there is nothing that we don’t offer at Elexes. Our experts will train your team well to get your product ready for inspection.
Data Integrity & GMP Consulting
We provide GMP inspection support and ensure that your device complies with the quality standards.
Outsourcing and staff augmentation
We have an excellent team of global regulatory experts who can help you with your regulatory compliance. Our FTE services will support you in all means possible to get the desired outcome. You can also get support from our team of medical doctors for KOL (Key opinion leader) engagement.
Medical Device Regulatory Consulting Services
Why Hire A Medical Device Regulatory Consulting Company?
To ensure that the product complies with the necessary regulations of any target market.
Gets you prepared for audits and avoids non-conformity during an audit.
Helps in suggesting and implementing strategies to avoid compliance risks.
Overcome obstacles and receive successful clearances/approvals through desired regulatory body.
Ensure you adhere to compliance with the updated regulations.
Considering to Hire a Medical Device Consultant?
Here is a complete guide we have prepared for you to make the right choice. In here you will get the tips on what to look for in a medical device consultant and also the reasons why your should consider hiring them.
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. With us, you not just get FDA regulatory consulting but support for other regulatory clearances as well. Get everything under one roof for your medical device!
Associated Regulatory Submissions
Popular Clients
We’ve 200+ Global Premium Clients
What are clients are saying about our services?
Client Testimonials
What Our Clients Say About Us?
Tom Birney
CEO Masterlink, Arizona
“Great work! Elexes team gave our organization immense support. Apart from being knowledgeable, and thorough; they were very responsive. All these are excellent virtues that I would look for when choosing a consulting firm.
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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.
“
Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing. “
Linda Pan
Sr. Exe Treedental, Hong Kong
“I’m a fan! We worked with Elexes on import-export regulations, and couldn't have asked for a better expert. Elexes' team was very patient in answering all our questions and guided us on every step. Will definitely work with them again!
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They are very responsive and have done a great job with our regulatory projects and document control set-up. They were easy to contact and were quite quick at understanding the nuances of our product. “
Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They’re always helpful and proactive. They are thorough and have provided invaluable support to us on 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! Created regulatory-compliant supplement fact sheets for multiple products. Their work helped us to sell within domestic & international markets without any problems. They were accurate and the turnaround time was amazing. “
Kurt Sysock
CEO Radformation, New York
“ Elexes promised and delivered a go-to organization for FDA regulatory and quality systems work. They have outperformed every expectation we had. “
Looking For Regulatory Assistance?
Let's Talk How We Can Help You?
FAQs
Frequently Asked Questions!
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The cost of regulating consulting usually varies as per the Intended market, industry you are in & type of the product. To know more, please connect with an expert at Elexes.
Regulatory consultants keep a check for any compliance risks during product development. They also assist you to create the right development strategy in compliance with the regulations of the market you wish to launch your product in.
Yes, it helps in assessing your product’s performance post launch and staying compliant with updated regulations.
It usually depends on your regulatory approval preparedness and the regulatory authority’s timeframe set for the particular type of product.
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.
