Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key tosetting up and maintaining arobust QS. Read More

Medical device labeling changes are made for a wide array of reasons.When a manufacturer makes changes to the labeling for a medical device,they must assess the impact of the change against their 510(k) clearance. Some changes may requirea new510(k) submission. Othersdon't require a new 510(k) submission but will require thorough documentation of the changes. Read More

In 2020, the most common reason for FDA's 483 observation letters was "procedures for corrective and preventative actions have not been [adequately] established." (1) Read More

The key to a successful quality audit is selecting a highly qualified auditor. Since the quality of your organizational processes directly depends on the audit's effectiveness, it's imperative to choose the right professionals for the job. Read More

For FDA (U.S. Food and Drug Administration)-regulated industries, organizations, and projects, the importance of data integrity is extremely high. Besides being a requirement for compliance reasons, data integrity is the foundation of a top-notch quality management systemand paramount for ensuring patient safety. Read More

Developing an effective regulatory strategy is more than following the step-by-step requirements outlined by a regulatory agency. It's a proactive process that helps you refine your product development goals and get your product to market faster. With the help of an experienced regulatory strategist, you can create a plan that addresses potential competitors, various regulatory requirements at... Read More

Quality managers everywhere will attest to the fact that effective document control is critical to the quality management systems — a process that is central to any regulated organization. And depending on just how efficiently document control is done, it can either make or break the company. Read More

Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requirement. By collecting evidence and evaluating it objectively, a company can determine how well its quality management system is performing, and support an environment of continuous improvement. An effective audit can identify areas of risk and opportunity. Even if the audit doesn't reveal any... Read More

Many executives only see internal audits as something that has to be done for compliance reasons. However, the reality is that an efficient and effective internal audit program can reduce redundancies, reduce risk,enhance customer satisfaction, and bring about cost savings. An effective internal audit will also improve efficiencies by identifying opportunities for improvement and eliminating... Read More

According to a recent survey by the Independent International Organization for Certification (IIOC), 38 percent of total audits (across 22 certification bodies) were delivered remotely in 2020. The year before, that number stood at a meager 1.75 percent. Read More