Medical device regulations are complex. They are also regularly updated and refined. So, rather than being a fixed set of rules, they constantly evolve. Therefore, it’s essential to have access to medical device regulatory experience and expertise during the application process.
Third-party regulatory support can be beneficial for companies of any size, but it is particularly helpful in organisations that have a limited level of in-house regulatory expertise.
What Support Can a Medical Device Regulatory Consultant Provide?
An experienced regulatory consultant can support all aspects of bringing a new medical device product to market. This includes regulatory compliance consultancy as well as support with clinical evaluations, literature searches, and more.
A medical device regulatory consultant can also help decide on the best regulatory pathway to use, before guiding your medical device product through the application and approval process.
The obvious objective of using a medical device regulatory consultant is to ensure your product obtains approval in the markets you want to target. However, it is also important to eliminate administrative errors. Minimising Additional Information requests is also beneficial. Both administrative errors and Additional Information requests elongate the regulatory decision-making process while also increasing your costs.
So, regulatory consultants can make a significant contribution, but how do you choose one? The following four tips will help.
You should engage regulatory support as soon as possible, as regulatory expertise can be helpful even in the earliest stages of the product design process. Your consultant can ensure the right documentation is being created, for example. They can also start developing a QMS for your product, and they can provide design and development advice from a regulatory perspective.
Ensure the Consultant Has Relevant Expertise
Check the regulatory consultant has experience submitting regulatory applications for devices that are similar to your product.
It is also important the consultant has experience in the regulatory pathway that is best for your product, as the process differs depending on your device and other factors. In the US, for example, 510(k) submissions are the most commonly used regulatory pathway for devices with a low-to-moderate risk, whereas the premarket approval (PMA) method is used for moderate to high-risk devices.
While there have been increasing levels of regulatory convergence between, for example, the US and EU, it is also beneficial to have regulatory experience in the market you are targeting – FDA regulations for the US market, MDR in the EU, etc.
Wider Expertise Is Also Beneficial
Regulatory expertise is essential, but it is also beneficial if the consultant you select has expertise in the type of product you are developing.
Expertise and capabilities in other parts of the process can also be helpful, including product design, DFM (design for manufacturing), design transfer, manufacturing processes, and more.
After all, for a product to be a commercial success, it needs more than regulatory approval. It also needs to be designed so it can be reliably, consistently, and cost-effectively manufactured.
Experience Working with Companies Like Yours
The needs of a medical device start-up are very different from a large organisation. Larger companies will have established procedures and systems, and they may also have a QMS and devices already on the market. This makes their needs very different to start-up companies, where agility and maintaining lean operations are often priorities. The medical device regulatory consultant you choose should have experience working with companies like yours.
A Regulatory Consultant is an Investment in Your Product
Did you know that 35 percent of FDA 510(k) submissions in 2021 didn’t pass the initial basic administrative check known as an acceptance for review? Or that Additional Information requests were needed in two-thirds of 510(k) submissions?
These two stats highlight the avoidable delays and unnecessary costs that can occur when applying for medical device regulatory approval. We can help at Arrotek. Contact us today for more information.