Maintaining oversight and control of your supply chain is a critical part of your organization's quality management system.  Effective and efficient supplier audits can have significant impact on long-term compliance profile and profitability. The quality of the audit doesn't just depend on the auditor's skills – preparation, contribution, and support by the audit sponsor is also essential. Read More

As product developers work to bring new concepts to reality, a regulatory affairs professional should be at hand to advise the team on effective regulatory strategies to get the product past regulatory authorities such as the FDA. However, choosing the right external regulatory affairs expert for your company can be a challenge due to the experience and expertise required to deliver the best... Read More

Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vine. It is the deciding factor in how long clearance takes: from 90 days to over six months. Lost months mean lost revenue and re-tasking resources that could be spent on other revenue-generating activities.  Read More

A supplier audit is one of the most effective ways to ensure your suppliers adhere to quality standards while meeting required promise dates. In addition to uncovering nonconformities and opportunities for improvement, audits remind suppliers that they must continually strive to fully conform to applicable customer requirements, standards, and regulations.  Read More

Internal audits are an essential part of quality management. Working with external auditors ensures you avoid conflicts of interest and have an independent perspective.  But how should your team interact with the auditor? Read More

Companies selling medical devices or pharmaceuticals are required by applicable regulations and standards to monitor the quality of the raw materials, components, and services that go into their products. For this reason, it is crucial that manufacturers have systems in place to ensure that purchases meet acceptable quality requirements. One essential and prevailing tool for this is the supplier... Read More

As the world continues to adjust to the COVID-19 pandemic's adverse disruptions, consideration must be given to how the medical device and pharma industries can best ensure business continuity of supply chain monitoring. A pandemic can impact most, if not all, suppliers, and prioritizing on-site audits can help reduce business disruptions going forward. Although it is essential to have ongoing... Read More

The medical field is continually evolving, and nowhere is that trend more evident than in the realm of medical devices. From wearable medical devices to increasingly smart data infrastructure, technology will take center-stage in 2021.  At the same time, regulatory bodies like the US Food and Drug Administration (FDA) are developing new guidelines to manage the increased reliance on these... Read More

According to Johns Hopkins Bloomberg School of Public Health, clinical medical intervention trials that companies use to support FDA drug approvals cost approximately $19 million per trial. While this may only be one percent of the total cost of developing a new drug or other medical intervention, it means creating a low-quality clinical trial — or getting low-quality data from the endeavor — can... Read More

The importance of preparing high-quality regulatory documents should never be underestimated. Low quality or poorly written submission documents may lead to expensive delays or rejection of regulatory approvals that can result in launch delays, extra costs, and compliance risks. Typically, submissions come with costs, which can be enormous depending on the type of regulatory filings.  Read More