Elexes Medical Consulting Pvt Ltd

When it comes to cosmetic labeling, there is so much to understand from the regulatory perspective. Every regulatory body be it the FDA, EU, or any other has a particular set of requirements when it comes to labeling your cosmetic product.

Here, we have listed all the necessary requirements as per the .

We hope you would find the article helpful.

If you are looking for professional assistance with cosmetic labeling, all you have to do is contact our experts at [email protected], or visit our website elexes.com.

Cosmetic Labeling | All about Labeling Requirements & more What is the FD&C Act & FPLA, how to correctly label cosmetics, Cosmetic labeling requirements, learn it all in this cosmetic labeling guide

Telemedicine is the latest technological development in the field of medicine. Where it has brought a new age of virtual consultations and remote patient care into picture, it has also introduced many challenges like cyberattcks etc.

Learn all about what is Telemedicine and how its regulatory approval process is different from conventional medicines here👇

Telemedicine | What it is & its regulatory requirements for approval? From what telemedicine are and how regulatory bodies approve them, learn it all here in our blog. Understand the regulatory requirements

We all know how challenging the compliance and regulatory journey could be. Considering these challenges, it is vital to get professional help. Medical device consultants will help you navigate through regulatory compliance, risk assessment, and other challenges that might create roadblock(s) in your approval journey.

Check out this post to learn why bringing an expert consultant on board could be your best move.

Swipe left to know in detail

Hello, MedTech pros and future healthcare specialists! 🌟

Ready to change the game with your medical device? Let's make sure you get that FDA approval first🚦 Here are 13 common 510(k) mistakes that could be tricky, but we’ve got your back.

🎯 Want the full read? Hit that link below!

FDA 510k Approval | 13 Common Mistakes to Avoid! Learn about the 13 common mistakes that one should avoid while filing for 510(k) approval with FDA and speed up the process.

Confused whether to hire a or not❓ Well! Let’s look at what these medical device regulatory and compliance agencies do that makes them valuable for any and all .

From to Interdisciplinary Collaboration, these consultants will offer support at every step of the process.

You can check the complete list 📋 of things that a medical device consultant can do for you here 👉🏻

Things to Consider Before Hiring A Medical Device Consultant! Learn what makes the medical device consultant best for hiring. Find the checklist here to never be wring with hiring a consultant again.

Defining a medical device classification can always be challenging. However, it is essential for any medical device company to classify its product accurately. You can aptly classify by:

- Verifying definitions
- Understanding objectives
- Evaluating modes of action
- Researching similar devices
- Seeking regulatory guidance
- Conducting thorough risk assessments
- Staying updated

Read more about classification here https://www.elexes.com/is-my-product-a-medical-device/

Let’s explore how FDA is classifying medical devices on the basis of their risk levels: Class I, II, and III. Where class I is the least risk device, class III is the riskiest of them all. Read the complete blog to know more about these classifications.

You can find more details on medical device classification in our blog - https://www.elexes.com/is-my-product-a-medical-device/

𝐌𝐃𝐑 𝐄𝐱𝐭𝐞𝐧𝐬𝐢𝐨𝐧: 𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐋𝐚𝐭𝐞𝐬𝐭 𝐂𝐡𝐚𝐧𝐠𝐞𝐬 𝐢𝐧 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬

The MDR and IVDR aim to improve the safety and performance of medical devices & IVDs, as well as increase transparency and accountability in the industry. The European Commission proposed an extension for the MDR deadline, which was later approved by the European Parliament and the Council of the European Union. The extension was granted to give manufacturers, notified bodies, and other stakeholders more time to prepare for the changes and ensure compliance with the new regulations. Let us look at the revised timeline here.

MDR Extension: Navigating the Latest Changes in European Medical Device Regulations - Elexes Introduction When it comes to placing medical devices on the market in the European Union, the Medical Devices Regulation has taken the role of the Medical Device Directive (93/42/EEC). All prior notices pointed to the 26th of May, 2024 as the last day of the MDR transition phase. However, recently....

𝐌𝐚𝐱𝐢𝐦𝐢𝐳𝐢𝐧𝐠 𝐓𝐚𝐥𝐞𝐧𝐭 𝐑𝐞𝐬𝐨𝐮𝐫𝐜𝐞𝐬 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐒𝐭𝐚𝐟𝐟 𝐀𝐮𝐠𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 - 𝐀 𝐂𝐚𝐬𝐞 𝐒𝐭𝐮𝐝𝐲

Are you looking to set up a procedure for hiring and training for your emerging healthcare organization?
Look no further, Elexes is here to help you. Our dedicated team of Quality professionals with years of experience is ready to support healthcare companies throughout the hiring and training process. If you have any questions, please email us at [email protected].

Maximizing Talent Resources through Staff Augmentation - A Case Study - Elexes Background A manufacturer developing healthcare products planned to expand their existing team for designing, manufacturing, and marketing and sought to register their products in the markets worldwide. However, they were concerned about the description of job requirements, the candidate shortlistin...

𝐊𝐧𝐨𝐰 𝐘𝐨𝐮𝐫 𝐅𝐨𝐨𝐝: 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐚𝐜𝐭𝐬 𝐀𝐛𝐨𝐮𝐭 𝐅𝐨𝐨𝐝 𝐀𝐝𝐝𝐢𝐭𝐢𝐯𝐞𝐬

While food manufacturers must add additives to food products as required, however, it is also important to know the regulations applicable to both the additives and ingredients. Did you know not all of these additives are regulated and not all of them are free from the regulations?

Confused? Here’s a sneak peek.

𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 𝐒𝐮𝐩𝐩𝐥𝐲 𝐂𝐡𝐚𝐢𝐧 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲: 𝐋𝐞𝐬𝐬𝐨𝐧𝐬 𝐥𝐞𝐚𝐫𝐧𝐞𝐝 𝐟𝐫𝐨𝐦 𝐚 𝐒𝐮𝐩𝐩𝐥𝐢𝐞𝐫 𝐀𝐮𝐝𝐢𝐭

Are you looking to conduct a supplier audit for your organization?

Look no further, Elexes is here to help you. Our dedicated team of auditors with years of experience is ready to support medical device and IVD manufacturers throughout the supplier audit process. Contact [email protected] today!

Streamlining Supply Chain Efficiency: Lessons learned from a Supplier Audit - Elexes Background A medical device manufacturer (legal manufacturer) developing therapeutic lasers and based in the United States had their contract manufacturer based in India. The contract manufacturer was responsible for the development and production of therapeutic lasers as per the service agreement.....

𝐇𝐚𝐩𝐩𝐲 𝐄𝐚𝐬𝐭𝐞𝐫 2023

Elexes wishes you all a joyful Easter filled with new beginnings and renewed hope. May this special day bring you happiness and blessings that last throughout the year. Happy Easter 2023!

𝐏𝐮𝐭𝐭𝐢𝐧𝐠 𝐲𝐨𝐮𝐫 𝐛𝐞𝐬𝐭 𝐂𝐨𝐬𝐦𝐞𝐭𝐢𝐜 𝐥𝐚𝐛𝐞𝐥 𝐟𝐨𝐫𝐰𝐚𝐫𝐝

Did you know that the contents of a cosmetics label are subject to regulations?

There is a lot to know about what should and should not be put on the package of a skincare product. Let's take a closer look at the key elements of a cosmetic label.

𝐎𝐯𝐞𝐫𝐜𝐨𝐦𝐢𝐧𝐠 𝐡𝐮𝐫𝐝𝐥𝐞𝐬 𝐨𝐟 𝐥𝐚𝐮𝐧𝐜𝐡𝐢𝐧𝐠 𝐚𝐧 𝐈𝐕𝐃 𝐢𝐧 𝐭𝐡𝐞 𝐄𝐮𝐫𝐨𝐩𝐞𝐚𝐧 𝐦𝐚𝐫𝐤𝐞𝐭

The accuracy and reliability of an In Vitro Diagnostic (IVD) are effectively communicated via the device's labeling. Correct and thorough labeling benefits physicians in making informed decisions about which tests to order and how to interpret the results. For any manufacturer, serious penalties, including fines and legal responsibilities, may occur for not adhering to IVD labeling rules. With an eye on ensuring patient safety, here’s how Elexes helped an IVD manufacturer to overcome its labeling challenges while designing or updating IVD labels.

Overcoming hurdles of launching an IVD in the European market - Elexes Background An in-vitro diagnostic (IVD) manufacturer was not familiar with the EU regulations and wanted to understand the general requirements that were needed to be fulfilled in order to market their products. The device utilized cardiac enzymes, also referred to as cardiac biomarkers, to identify...

"𝐌𝐚𝐱𝐢𝐦𝐢𝐳𝐞 𝐲𝐨𝐮𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐅𝐓𝐄 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬”

Discover how Full-Time equivalent services can provide you with a dedicated regulatory consultant to ensure your organization stays compliant with regulations, streamlines processes, and achieves success. Watch the video to learn more about the benefits of FTE services for your regulatory needs."

Get in touch with Elexes today and explore our FTE services!

𝐌𝐚𝐱𝐢𝐦𝐢𝐳𝐞 𝐲𝐨𝐮𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐅𝐓𝐄 𝐒𝐞𝐫𝐯𝐢𝐜𝐞𝐬 Discover how Full-Time equivalent services can provide you with a dedicated regulatory consultant to ensure your organization stays compliant with regulation...

𝐇𝐨𝐰 𝐭𝐨 𝐠𝐞𝐭 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐟𝐨𝐫 𝐚 𝐓𝐫𝐢𝐚𝐠𝐞 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞?
Would you like to place your device in the US market?

Elexes can be of assistance to you. Our hardworking team has years of experience in helping customers through this process. Please get in touch with us at [email protected] so we can examine your equipment in accordance with FDA guidelines and walk you through the necessary steps further.

How to get regulatory approval for a Triage Software? - Elexes Radiological computer-assisted triage and notification software is a form of image processing software. Based on computer-assisted image analysis done by the device, the device alerts a predefined list of doctors when time-sensitive radiological medical images are available for examination. Using th...

𝐄𝐧𝐭𝐞𝐫𝐢𝐧𝐠 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐔𝐒 𝐌𝐚𝐫𝐤𝐞𝐭 𝐰𝐢𝐭𝐡 𝐚𝐧 𝐔𝐥𝐭𝐫𝐚𝐬𝐨𝐮𝐧𝐝 𝐁𝐫𝐨𝐧𝐜𝐡𝐨𝐬𝐜𝐨𝐩𝐞 𝐯𝐬. 𝐚𝐧 𝐔𝐥𝐭𝐫𝐚𝐬𝐨𝐮𝐧𝐝 𝐟𝐨𝐫 𝐛𝐫𝐞𝐚𝐬𝐭 𝐜𝐚𝐧𝐜𝐞𝐫 𝐝𝐞𝐭𝐞𝐜𝐭𝐢𝐨𝐧

Explore the challenges and opportunities Elexes faced in bringing innovative ultrasound bronchoscope and ultrasound for breast cancer detection to the US market, and how we overcame them to achieve success. Elexes' journey serves as a testament to the power of perseverance and strategic planning in the healthcare industry. For questions and comments please feel free to contact us at [email protected]

https://lnkd.in/gTVqC4SZ

Entering into the US Market with an Ultrasound Bronchoscope vs. an Ultrasound for breast cancer detection - Elexes Background A medical device company was looking to understand the FDA classification and regulatory framework that is needed to be considered for an Automated Breast Ultrasound (ABUS). The company wanted to engage a qualified and skilled team to help them with various problems that they were facing....

𝐇𝐨𝐰 𝐰𝐞𝐥𝐥 𝐝𝐨 𝐲𝐨𝐮 𝐤𝐧𝐨𝐰 𝐚𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐢𝐧𝐠𝐫𝐞𝐝𝐢𝐞𝐧𝐭𝐬 𝐢𝐧 𝐲𝐨𝐮𝐫 𝐜𝐨𝐬𝐦𝐞𝐭𝐢𝐜𝐬?

Someone rightly said, “Good food depends almost entirely on good quality and the right level of ingredients”. This holds true not just for food but also for drugs, cosmetics, and biologics in order to get the best results in the safest manner. If you are a cosmetic manufacturing company, and developing products, it is important for you to know your ingredients and make sure they are compliant with the FDA-prescribed levels. Feel free to reach out to Elexes to get your cosmetics ingredient list reviewed.

𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐨𝐧 𝐃𝐢𝐚𝐠𝐧𝐨𝐬𝐭𝐢𝐜𝐬 (𝐂𝐃𝐱): 𝐓𝐡𝐞 𝐟𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐬𝐚𝐟𝐞 𝐚𝐧𝐝 𝐞𝐟𝐟𝐞𝐜𝐭𝐢𝐯𝐞 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬!

Want to place your Companion Diagnostic device in the US and international markets?
Elexes is here for your support. Each member of our diligent team has years of experience guiding clients through this process. To get your equipment and therapeutic products reviewed for compliance with applicable regulations, write to us at [email protected] and we'll be happy to assist you.

Companion Diagnostics (CDx): The future of safe and effective therapies! - Elexes A Companion Diagnostic (CDx) Device is often an In-Vitro Diagnostic (IVD) device that specifies the conditions for use of another product, like a drug or a biologic. A companion diagnostic may ensure the safety and effectiveness of a product. A CDx falls under the subset of biomarker-oriented testin...

10 𝐭𝐢𝐩𝐬 𝐭𝐨 𝐦𝐚𝐤𝐞 𝐲𝐨𝐮𝐫 𝐧𝐞𝐱𝐭 𝐆𝐫𝐚𝐧𝐭 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐚 𝐬𝐮𝐜𝐜𝐞𝐬𝐬!

Grant applications must be viewed as projects with a clear deliverable or goal in order to get the requested funding. Projects must produce measurable results in order to receive financing. Determine your proposal’s hook — the essential element — and then tell a compelling story that connects each experiment to your core goals. A carefully crafted, organized, and packed grant proposal is one that will be accepted. If you want to get your grant proposal approved, Elexes is here to help you out. Elexes with an expert set of grant authors and reviewers can help you compose and review an effective grant proposal. Feel free to contact us at [email protected] for your next grant application!

10 tips to make your next Grant Application a success! - Elexes A grant proposal is a set of documents that are submitted to a company with the specific goal of receiving grants for a project. The process of drafting an effective grant proposal starts with a concept. To convince others to support your project, it is crucial to clarify the ultimate goal and purpo...

𝐈𝐦𝐩𝐨𝐫𝐭𝐢𝐧𝐠 𝐂𝐨𝐬𝐦𝐞𝐭𝐢𝐜 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐔𝐒? 𝐓𝐡𝐢𝐬 𝐢𝐬 𝐰𝐡𝐚𝐭 𝐲𝐨𝐮 𝐧𝐞𝐞𝐝 𝐭𝐨 𝐤𝐧𝐨𝐰!

Before importing cosmetic items into the US, what should manufacturers or distributors bear in mind? If you are an importer or distributor of a cosmetic product it is vital for you to know FDA’s critical checkpoints for safety and suitability. Elexes is here to help you understand the requirements for importing your cosmetics into the US.

Importing Cosmetic into the US? This is what you need to know! - Elexes What are cosmetics? Cosmetics are substances that are applied to the human body (except pure soap) to enhance beauty, cleanse, make it more appealing, or transform its appearance. They have no physiological impact on the body. Legally, a cosmetic will also be considered a drug, if it intends to alte...

How are Dietary Supplements regulated in the US?

Are you a company developing, distributing, manufacturing, packaging, or labeling dietary supplements? You must be aware and be in compliance with the necessary regulations and requirements to avoid any product recalls, suspension of registration, warning letters, or other adverse actions from the regulatory authorities. Contact us today at [email protected] to learn more about what requirements are applicable to your dietary supplement and how to comply with them.

How are Dietary Supplements regulated in the US? - Elexes What are Dietary Supplements:  Dietary supplements are additions to the standard diet which are quite distinct from the ingredients found in conventional foods. The use of dietary supplements has witnessed an upsurge in mass consumption over the past several years, as many people have made staying ...

Grant Process — All you need to know!

Grants can take your organization closer to achieving your goals and making a real difference. However, a company should have a realistic grasp of the grant process, as well as the time and resources necessary to submit a competitive proposal. It can ensure that the right personnel is involved in this without compromising the existing operations at the company.

Elexes is here to help you in these areas. Our dedicated team has years of experience in supporting our clients in acquiring grants. Please contact us at [email protected] to let us help you gain the funding you need for your endeavors.

Grant Process - All you need to know! - Elexes A grant is often given to an organization by a foundation, company, or governmental entity and is defined as “a financial donation provided to support a person, organization, project, or program.”. Grant money should account for 10% – 20% of your overall organization budget, depending on the s...

Biologics, their Unique Characteristics, Applicable Requirements, and Regulations

Given the complexity of a Biologics product and its corresponding regulatory submission (BLA), it is of essence to involve the FDA at the right stage of product development and to discuss the validation plan before companies submit the application. The right extent, presentation, and type of information submitted in a licensing application of a BLA go a long way in getting timely approval. For any questions related to your upcoming biologics product please feel free to write to us at [email protected].

Check out our Article: https://lnkd.in/ggUugd2s

Biologics, their Unique Characteristics, Applicable Requirements and Regulations - Elexes The market for biologics is expanding, and it is foreseen that it will grow at a Compound Annual Growth Rate (CAGR) of 9.22% during the subsequent five years. The COVID-19 pandemic had a considerable effect on the market, and there was a massive demand for biologics, which significantly fueled the m...