Challenges and Solutions for Borderline Products

What constitutes a borderline product?

You may be developing a product that is a challenge to classify. It is not always straightforward to make a distinction between a medicinal product and a medical device. Sometimes, it is a challenge to even determine if a certain product is a medical device or not. A gel, for example, could qualify as a medical device in one country and a drug in other countries. No matter the case, this is a decision that needs to be made early on in product development. At SDS MTQ, we help answer those tricky regulatory and quality questions that can help developers make this choice with confidence.

Making the right decisions from the start

Making this choice involves understanding what product development strategy, the budgets and timelines would look like in the future. So, you can make the right decisions from the start. At SDS MTQ, we have experts within various disciplines who can provide valuable guidance regarding the various phases of product development. This includes regulatory strategy, technical documentation, the extent of clinical data needed, implementing a Quality Management System and so on. Our project managers review the overall project strategy and ensure that appropriate experts are not only engaged but are engaged at the right time. This one-stop-shop approach provides an overview of product development and compliance from start to finish.

Working in close collaboration with SDS Life Science

As a result of our collaboration with our sister company SDS Life Science, borderline products can be viewed through multiple lenses including drugs, biologics and medical device or in-vitro diagnostics (IVD). At the end of the day, we help you see the big picture and the possible outcomes. This is largely because our people have also worked on the other side of the table. They have been part of regulatory agencies and Notified Bodies having reviewed multiple regulatory submissions from companies both big and small.  This further adds to our flexibility.

So, whether you are a start-up or a medical device giant, we understand the differences and complement the flow you have set. That said, many of us have a decade long experience in various phases of medical device development. So, no matter where you are in your development journey, we’d be happy to partner with you.

 

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