New Product Approval for Medical Devices
Most of the medical equipment manufacturers and companies would agree that regulatory changes are 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 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.
Looking for new product approval support?
Look no further!
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…
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 country's do we offer our services in? Check if your target country is on our list
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.
Our Services
Market Feedback Analysis
We analyze customer feedback and market trends to identify potential product improvements…
Read MoreRegulatory Updates and Compliance
Our experts stay up-to-date with evolving cosmetic regulations and ensure your products…
Read MorePost-Market Surveillance Reporting
Our team helps in preparing and submitting necessary post-market surveillance reports to…
Read MoreProduct Quality Monitoring
We provide guidance on establishing quality control processes to monitor the consistency…
Read MoreCorrective and Preventive Actions (CAPA)
In case of any product-related issues or non-compliance, we help you plan…
Read MoreCustomized Post-Market Surveillance Plans
We create tailored post-market surveillance plans to meet your specific product and…
Read MoreProduct Recalls and Withdrawals
If necessary, we assist in planning and executing product recalls or withdrawals…
Read MoreOur 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.
Expertise
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
Customized Solutions
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
Efficiency
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Compliance Assurance
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
Confidentiality
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
Looking for someone who can assist you?
Contact us
Elexes Team
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.
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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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