New Product Development
New Product Development
Most of the medical equipment manufacturers and companies would agree that regulatory changes is one of the primary challenges they face. With the ever-evolving medical device industry, the regulations are also becoming more gruesome day by day. Getting familiar with all these regulations can become quite overwhelming for any medical device company working on creating a new product. This is why, it is critical to find a professional support to get medical device approval from different regulatory bodies across the globe.
At Elexes medical consulting, we have a team of experts who will guide you through both domestic and international regulations at any phase of your medical device development process. From pre-submission strategies to international submission support, we will hold your hand throughout your new product approval process.
On the other hand denoue with right indignation
At vero eos et accu samus dignissimos ducimus
Nam libero tempore cums soluta nobis cumque
Blame belongs those Who duty through weakness
Welcome To Elexes
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 -
Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…
Domestic & International submission
We have an efficient team of professionals who will help you get medical device approval through your choice of regulatory body. Whether it is a domestic or international approval you seek, we will help you get it. Technical documentation, pre-market approval, innovative regulatory pathways, facilitation & interactions with regulatory authorities, we offer a wide range of support to get new product approvals.
Which countries’ do we offer our services in? Check if your target country is on our list
Expert Regulatory Guidance:
Our team of regulatory consultants possesses a deep understanding of global cosmetic regulations. We keep abreast of evolving guidelines to provide you with the most up-to-date insights.
Precise Labeling Evaluation:
We meticulously review your product labels, scrutinizing every detail to ensure compliance with local and international regulations. From ingredient listings to claims substantiation, we leave no stone unturned.
Why Choose Our Service?
Claims Substantiation:
Making bold claims about your cosmetics? We help you substantiate them with scientific precision, ensuring your marketing messages align with regulatory requirements.
Risk Mitigation:
Our proactive approach identifies potential compliance pitfalls, allowing you to address issues before they become costly setbacks.
Consumer Trust:
Accurate labeling and substantiated claims foster consumer trust. We help you build a brand that stands out for its transparency and commitment to compliance.
Post-submission services
Unlike what you might think, getting clearance/approval for your product is not the final step in the process. You will need to register, list your device and identify the changing and evolving regulations to ensure that your product remains compliant. We will have a dedicated professional assigned to keep a check on the compliance of your medical device post launch.
Have a question for us?
Let’s get on a call
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.
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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.
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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 excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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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.
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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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