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.

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.

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.

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Understand everything about PMA submission!

In this guide, we have discussed everything about PMA right from what it is, its process, and submission requirements.

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.

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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!

Have a new medical device for which you need regulatory support?

Our experts will guide you...

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FAQs

Frequently Asked Questions!

Learn what most of our clients ask while taking drug regulatory and compliance services.

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.
How much will it cost to get support from professional regulatory consultant?
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.
How do regulatory consultant help with product development
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.
Is post-market surveillance and vigilance required?
Yes, it helps in assessing your product’s performance post launch and staying compliant with updated regulations.
How long will it take for my product to get approved?
It usually depends on your regulatory approval preparedness and the regulatory authority’s timeframe set for the particular type of product.
Do you offer regulatory services in UAE?
Yes, we do. You can check the complete list of countries we serve here .
How much experience do you have?
In Elexes Medical Consulting we have a collective experience of 50+ years in providing regulatory & compliance assistance to all the industries.

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