FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Medical Devices ~ FDA Consulting Services

At FDA Compliance Group, our FDA consultants have worked for the FDA, or have extensive industry experience. We bring this medical device expertise as a resource to determine the root cause and resolve compliance and quality control issues for our clients.

We can help you meet your FDA compliance and regulatory goals by providing the following FDA consulting services and FDA training.

FDA cGMP Compliance Audits and Gap Analyses
We can evaluate the level of FDA compliance of your manufacturing, quality, and laboratory systems, (with 21 CFR Part 820 and other applicable FDA regulations), and advise on the steps needed to become fully FDA compliant. On your behalf, we can also audit third party facilities, including contract manufacturers and laboratories, and vendors / suppliers.

FDA Inspections and FDA Warning Letters
We can steer you through the complex process of responding to an FDA Form 483 (Inspectional Observations) or an FDA Warning Letter for medical devices. Often, a well-formulated 483 or Warning Letter response can prevent further regulatory action by the FDA. We can assist with all facets of an FDA inspection, from pre-audit preparation to onsite FDA inspection support, ensuring that you are fully prepared for inspection.

FDA Recall and MDRs
We can provide guidance for your recall and MDR (Medical Device Reporting) systems, ensuring that that they are in complete compliance with all FDA requirements. We can also advise on the steps needed in case of FDA product recalls, corrections, removals, or other FDA regulatory actions.

FDA Procedures, Documents, CAPA
We can write and help you execute cGMP compliant procedures, work instructions, and protocols. We can develop medical device master and history records that meet all of the applicable FDA regulations. Additionally, we can help you set and write your Management Control system, Production and Process systems, CAPA program, Design Control, and Sterilization programs to ensure that they are functioning smoothly and correctly.

FDA Validation
We can validate your processes and equipment (IQ, QQ, PQ) and ensure that the validations are adequately documented, as required by the FDA for all medical devices. We validate computer applications for software and 21 CFR Part 11 compliance, including manufacturing, product operating, and laboratory information systems, data collection and storage systems, EPR software, and more. We can also assist with cleaning validation, including protocol development and test report writing.

FDA Quality System Development / Ongoing Maintenance
We perform a wide range of FDA consulting services, including: GAP analysis of your existing Quality System; review and recommendations for enhancements to organization structure; and QSR SOP development, review, and training. We can develop metrics and reporting requirements which monitor for continual improvement of your Quality System. Additionally, if your company is in the start-up phase, we can assist with complete development of an FDA compliant, sustainable Quality System.

FDA Regulatory Affairs Assistance
We can review your websites and labeling to ensure FDA compliance for marketing and promotion of medical devices. We can also prepare IDEs, 510(k), and PMA submissions. Additionally, we can provide nonclinical, clinical, and product safety assessment guidance leading up to product commercialization or acquisition.

Special Services
We can assist you with design control development and implementation, training on CAPA and root cause investigations, international facility audits, and development of specific training for your organization.

For more information on FDA consulting services for medical devices or to schedule a consultation, please contact us.