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Medical device companies have to comply with many different regulations with US regulatory agencies and globally. At times this can feel burdensome and overwhelming; however, manufacturers should keep the bigger picture in mind and build regulatory compliance into their company’s culture. Ensuring regulatory compliance can provide companies with the assurance their product is safe for the market, better audit experiences, regulatory clearances, and strategic advantages. Public Safety The FDA’s mission is to protect and enhance public health. Medical device manufacturers share a similar mission. Whether a company develops diagnostic tests or implants, they are both trying to protect and enhance health. The regulatory process is a proven process that works to ensure products enter the market safely. Manufacturers who try to cut corners or bring products to market without full transparency will likely end up causing some harm to patients or the public. To ensure public safety, manufacturers must comply with FDA regulations. Smoother Audits The FDA audits records for all registered medical device manufacturers and distributors. FDA audits tend to be shorter in length for manufacturers who comply with regulations. If documentation is disorganized and incomplete, the FDA will continue the audit process and investigate the company further. Audits that last longer will end up using company resources and time, which could delay manufacturing, new product development, or other business activities. Rather than having a complex, timely audit, it is more efficient for organizations to comply with regulations and have a smooth audit experience. Regulatory Clearances Obtaining FDA regulatory approval is often an indicator globally that a medical device meets the current standards of quality. Complying with FDA regulations and obtaining clearances will signal to other global regulatory bodies that the product is safe for their market. Better Relationship with Regulators Manufacturers that are consistently compliant and have good audit records tend to have better relationships with regulators and are viewed as market leaders. While FDA and regulators don’t necessarily soften regulations, they will be more receptive to discussions and feedback from manufacturers who consistently meet their expectations. This can allow for opportunities to work with the FDA on new product-specific regulations, experiential learning programs, and opportunities to provide FDA with feedback, resulting in strategic business opportunities. Regulatory Compliance Culture Manufacturers should build a company culture around quality. Part of this includes creating a quality policy and including regulatory compliance as part of the company’s quality initiative. A culture of regulatory compliance will allow employees the opportunity to speak up if they are feeling pressured to move too rapidly and can’t meet compliance requirements. DeviceLab is here to help your organization’s compliance needs. Whether you are looking to re-build compliance into your organization or prepare for audits, DeviceLab is here to help. Contact DeviceLab today to schedule a consultation.

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Why is Medical Device Compliance so Important?

FDA Classification Overview: Class III Medical Devices