Regulatory Compliance Associates^® Inc.’s breadth of expertise in the Medical Device industry is globally renowned and in demand. Our broad range of regulatory services include regulatory support such as regulatory staff augmentation; global regulatory strategy and submissions; regulatory due diligence, assessments, and audits; regulatory augmentation; and strategic consulting on new product development, lifecycles, and staffing support.

The regulations process surrounding medical devices involves a strict adherence to regulatory compliance throughout a device’s life-cycle. Even a single compliance issue can have a significant effect on your business. RCA helps guide you through any stage of this challenging process, both during product development through to the clearance/approval of your product. Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such as:

• Anesthesiology
• Cardiovascular
• Combination Devices
• Dental
• Ear, nose and throat
• Gastroenterology
• General hospital
• Gynocology
• In Vitro Diagnostics
• Orthopedic
• Radiology
• And more

Our experts are available to assist in an array of services for businesses in the medical device industry. Contact us using the form below to learn more about our flexible medical device regulatory compliance and quality assurances solutions.