New Medical Devices: How to Meet Compliance and Safety Standards in the USA

by | Oct 25, 2023 | Business

You have created a rough sketch to begin creating a prototype of a medical device that can quickly, effectively, and safely deliver certain types of medication. You are fine-tuning your sketch to help ensure every detail is addressed. What is next?

Your Materials List

The next step to turn your sketch into a tangible prototype is to begin compiling a list of materials you will use to assemble your unique device. To begin, you must first consider the materials that are not only suitable and durable to use for your application, but also ensure the chemical compounds of these materials will be safe for human use. You will need to assess the risks and effects they may have on patients, helping to ensure safety, compatibility, and compliance.

Toxicology

As you may be aware, toxicology is a field of medicine that overlaps biology, chemistry, medicine, and pharmacology. This field involves studying adverse effects on humans. So, what does this branch of medicine have to do with your invention? Everything. It will be used to help meet compliance standards while also ensuring that you are offering a safe product.

Get Back to Focusing on Developing Your Invention

You would like to get back to developing your invention and now require the assistance of a company that offers toxicological risk assessment services for help. Contact JL Tox Consulting, LLC. They are the leading medical device consulting firm in the market with several decades of combined expertise. They understand your compliance and safety needs for your one-of-a-kind invention by offering services that include impact assessments, gap assessments, toxicological risk assessments, biocompatibility test plans, and biocompatibility evaluations. Visit jltox.com today.

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