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Author: Anne Holland, Founder and CEO

Today’s medtech startups are bringing novel and innovative medical devices to market every day. After a quiet year in the industry due to the COVID-19 pandemic, analysts are bracing for a Mergers & Acquisition boom that will inject funding into new projects across the industry. With the pace of new technology, an efficient and effective medical device startup quality system that will ensure products are safe and work as intended is more critical than ever.

As a regulated industry, keeping up-to-date with the technology while also navigating the complexities of the regulatory environment can be challenging.

Our team of experts developed a downloadable white paper to aid medtech startups and small medical device manufacturers in commercializing their products.

What is a Quality-First Approach?

A quality-first approach to bringing your medical device to market means prioritizing quality assurance and regulatory compliance at every stage of the product life-cycle.

Whether it’s generating standard operating procedures (SOPs) or filing the required paperwork with the FDA, an eye to quality is essential.

To take a quality-first approach from an idea to reality requires a well-thought-out plan tailored to meet your business objectives.

Project plans are not one-size-fits-all, and when it comes to medical devices, the type of device, the amount of contact it has with a patient, and its component materials greatly influence the quality and regulatory requirements.

Lean into our Medical Device Quality System Startup Expertise

Your medical device quality system might not be the most glamorous part about bringing a new product to market, but it is an essential one.

Failure to adopt a quality-first approach to bringing your medical device to market will not only take the wind out of your sails but may also result in numerous product delays and unexpected costs.

Find an innovative medical device consulting partner with the knowledge and experience to apply industry best practices to your unique ecosystem. Learn more about the medical device startup process and how we can help.

Download our actionable guide for startup success.