Learn about the requirements for biomedical engineering firm licensing.

What Is Biomedical Engineering?

Biomedical engineering is applying the principles and problem-solving techniques of engineering to the subjects of biology and medicine. The industry focuses on the advances that improve human health and health care at all levels. Subdisciplines of biomedical engineering include:

• Biomedical signal processing
• Clinical engineering
• Design and development medical devices (active and passive)
• Medical imaging
• Orthopedic implants
• Tissue and stem cell engineering

Biomedical engineers differ from those in other engineering disciplines because they use and apply knowledge of modern biological principles in their engineering design process. Aspects of mechanical engineering, electrical engineering, chemical engineering, materials science, chemistry, mathematics, and computer science are all integrated with human biology in biomedical engineering, with the objective of improving human health.

How to Start or Expand a Biomedical Engineering Firm

Practicing biomedical engineering is inherently complex, so owners of firms need to ensure they abide by state and local requirements when registering and expanding their businesses. Requirements revolve around the business registration and licensing process, insurance, and continuing education.

Business Registration

The process to register your business will depend on your state’s requirements. In general, you will go through the following steps:

• Research your state’s business registration and licensing requirements.
• Choose your business name and entity structure.
• Obtain a federal tax identification number from the Internal Revenue Service and register with the secretary of state.
• Obtain necessary types of insurance, including general liability, commercial auto, and workers’ compensation.
• Research license and registration renewal requirements and prepare to keep your business compliant.

State Licensure

Licensing requirements for biomedical engineering companies vary by state. It is essential to verify the process in your state to ensure you are prepared every step of the way. You will likely need to gather all relevant documentation, including financial statements, proof of a commercial activity license, a business plan, and more. You will also need to appoint a registered agent to receive notices of lawsuits and other legal or government notices.

After your license has been issued, you will receive notice to pay any related balances. If the application is not approved, you will receive notice regarding what is missing or required.

Meeting the biomedical engineering license requirements is not always an easy process. Fortunately, the Harbor Compliance License Manager helps healthcare professionals and firms maintain their licenses by automating repetitive tasks such as tracking renewals and filing deadlines. Through License Manager, you can also access Compliance Core™ - our extensive, proprietary licensing database - to research over 8,000 nationwide requirements for states where you operate. Contact our licensing experts today to learn more.

Insurance

As with any other engineering field, biomedical engineering is inherently dangerous. To protect your business, it is essential to have a risk management plan in the form of insurance. Proof of insurance is also often required when applying for licensing. The most common insurance policies biomedical engineering companies adopt include the following:

• General liability - covers bodily injury, care, custody, and control coverage, errors and omissions endorsement
• Umbrella liability - this in-house binding authority combines all policies discussed above up to $10,000,000
• Workers’ compensation - covers bodily injury within the scope and course of employment

What is best for your business depends on your location and the types of services you provide. Contact an insurance specialist to learn about your options.

Continuing Education

Some states require continuing education credits in engineering throughout the years you operate a business. This ensures business owners and employees keep up with new regulations, engineering methods, and more. The amount of training required and frequency varies by state.

Maintaining and Renewing Licensure as a Biomedical Engineering Firm

No matter what stage you are in with your business, you need to maintain your license’s status. State requirements vary, but renewals are often required annually or biennially. You may need to submit a renewal application, pay a renewal fee, or pursue continuing education. Complying with renewal requirements will ensure you can continue to operate your business without disruption.

Keeping on track with your business’s license renewals can be complicated, especially as a growing company. At Harbor Compliance, our managed annual reporting and registered agent services ensure accurate due date tracking and on-time filing. This way, your business will continue to be compliant with state and local requirements, and you will have the time you need to continue working and expanding your clientele.

If you are currently operating a biomedical engineering firm and are looking to outsource your maintenance and renewal duties, Harbor Compliance can help. We are available to review your business status, ensure you are in good standing in the state where you operate, and explain what steps you need to take to ensure you remain compliant with state and federal regulations.

Explore Licensing by State

Click on a link below to view licensing information in your state.