Understanding Medical Device Regulation Needs and How We Help You Bring A Product to Market

understanding medical device regulations

Navigating medical device regulations and obtaining product approvals on your own is a daunting and challenging task. Understanding and applying medical device regulations effectively can make or break a company for any new technology. At E4D Technologies, we have the industry knowledge and expertise to help you understand the requirements of global medical device regulations and how to bring your product to market as soon as possible. Here are some ways E4D can help you:

Understanding Medical Device Regulation by Country

Every country has its own set of rules when it comes to a new product introduction. Medical devices are regulated by the FDA in the United States, by Health Canada (HC) in Canada, the NMPA in China and, the European Commission (EC) in the EU. With many countries having their own set of rules, licensing requirements and labeling regulations, this can cause a whirlwind of confusion for any company trying to manufacture medical devices. Through our experience, we’ve learned that meeting all the requirements for one organization’s set of rules doesn’t always mean that you’ll be able to get clearance in other countries. China always requires in-country testing regardless of approval from other countries. In Europe, the regulatory process is quite different than that of the US.

Not all medical devices are regulated equally. Since medical devices will use different technology and materials, and will have different indications for use, the risk of each category of device is treated differently. For instance, a medical device implanted in a person’s heart will have to undergo rigorous testing. The company will have to report in great detail about any life-threatening occurrences that may happen as well as serious, minor or if no injuries have occurred. These high-risk devices have to complete long and detailed clinical trials and often take several years before they can be introduced into the market. Even some PPE products could fall into life-threatening high-risk categories. On the other hand, lower risk devices such as many dental devices and non-invasive devices are able to enter the market much faster.

Assessing Risk and Establishing Benefits through Research

Every government medical device regulation can be connected to keeping patients safe and to the device’s effectiveness while clearly defining the risks. Medical device product development requires risk assessment and extensive research and testing of the product. The main questions government regulatory entities will ask are, “does it do what you claim it will do?”, “is it safe and effective for your claimed indications for use?” and “is it substantially equivalent to your claimed predicate device?” Taken directly from the FDA, “The legally marketed device(s) to which equivalence is drawn is known as the predicate device(s).” While your product is going through the development life cycle, you and your team will need to ask yourself:

● Does the device do what it claims to do?
● What is the risk of this product failing?
● What are the failure points?
● What happens if the product fails? Will failure create serious or life-threatening risks?
● How can we prevent the device from failing in high-risk situations?
● Do the benefits of using the device outweigh any residual risks?

Developing a medical device can take a lot longer than anticipated. The leading cause for companies failing to bring a medical device to market is usually connected to establishing substantial equivalence to the chosen predicate device. The key in this stage is to have a comprehensive timeline with attainable goals and room for error. Many unforeseen obstacles can appear during the development phase, and we always advise our clients to plan for the unknown.

Testing, Manufacturing and Bringing It to Market with E4D

Bringing your new medical device to market is extremely difficult on your own. Meeting with experts in the industry who have established experience is one of the best ways to bring your medical device to market. One route you may consider going down is hiring an independent medical technology consultant. This may require a significant amount of funding, time and resources because most consultants are expensive. Without having to bust the bank or causing you to take two steps back with your new technology, we would eagerly lend you a helping hand.

At E4D Technologies, we have a dedicated team of experienced technology consulting experts, technology logistics personnel and global supply chain leaders. We have worked with companies to help bring their new product to market, and we’ve helped them navigate through a broad range of medical device regulations. Our team can help you with development, usability, testing, risk assessment, regulatory/compliance submissions and manufacturing, all under the same roof. You need someone who can ask the right questions, give you the correct answers, guide you through any process and be realistic with you every step of the way. Our experienced team knows how important your business is to you, and we want to help you succeed.

Whether you are looking for a new manufacturing partner or you need an experienced team to help you navigate medical device regulation requirements, the team at E4D Technologies wants to hear from you. With unique experience and specialties covering all major technology and manufacturing disciplines, we’re confident that you’ll find exactly what you’re looking for through E4D Technologies. Understanding and meeting regulations and requirements for new technology and existing technology doesn’t have to be overwhelming, and we’re waiting to hear from you today.

Want to learn more about what E4D Technologies has to offer your business? Contact our team to find out how we can help and meet your specific needs.

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