The hard truth is, regulatory compliance can make or break your business — especially for those in the biotech or medical industries. And understanding, not to mention navigating, the many rules and processes imposed on health-related businesses can pose a truly immense challenge for companies looking to make it in the US. 

As Founder and CEO of Preferred Depot, I have built my career on helping some of the world’s largest medical and health technology companies thrive in the US market — with state-of-the-art, white label operations management and regulatory compliance services. 

So, to get you started on the path to success, let’s dive into all that that entails and how to achieve regulatory compliance for your business.

What Is Regulatory Compliance?

Regulatory compliance refers to following a set of unique rules, processes, and procedures required to operate legally within the laws, regulations, and guidelines set forth by the government of the area your business operates in. Ultimately, these rules can vary significantly from country to country — but also from state to state.

Why Is Compliance So Important In the Biotech and Medical Industries?

Industries providing healthcare products or services are very highly regulated. Without proper regulatory compliance, companies open themselves up to a potentially insurmountable amount of legal risks that could prove detrimental to their company. One wrong move and the reputation, trust, and capital you have worked so hard to build is diminished — especially for companies in the biotech and medtech industries. 

What Is the Landscape Like for Medical Device Companies Operating In the US?

In the US, companies involved in selling, refurbishing, or repairing medical devices must comply with stringent regulatory laws. From the moment a product is imported or enters the refurbishment process, thorough documentation is required to ensure traceability and regulatory adherence. 

How Can Medical Device Companies Ensure Compliance?

Implementing ISO standards, such as ISO 13485, is essential for managing internal processes and Standard Operating Procedures (SOPs). These standards help maintain quality control, ensure consistency in repairs or refurbishments, and demonstrate compliance with FDA and other regulatory bodies throughout the product’s lifecycle.

How Can Companies Best Navigate Regulatory Compliance?

Navigating compliance can be a nightmare for businesses looking to break into the US market. Luckily, there is one clear way to maintain regulatory compliance — without breaking the bank. Work with an operations consulting company with the key knowledge, certifications, and licenses to ensure your business always stays above board… a company like Preferred Depot.

Why Should Companies Work with Preferred Depot?

As the premier white-label operations consulting and management partner for medical device, biotech, and healthcare companies looking to launch or scale in the US, our team is uniquely positioned to ensure your business maintains compliance and avoids potentially catastrophic risks.

What Licenses and Certifications Does Preferred Depot Have?

Preferred Depot is an FDA-registered facility with a California medical device manufacturing license and California State Board of Pharmacy certification as a third-party logistics provider for sensitive medical products. We are ISO 13485:2016 and ISO 9001:2015 certified and have extensive experience in these critical life-science and tech industries. 

At Preferred Depot, we exist to help biotech and medical businesses like yours launch, grow, and thrive in the US — so your products can make an even bigger impact. To learn more about Preferred Depot’s white label operations management and regulatory compliance services, visit us at https://www.preferreddepot.com/.