In the rapidly evolving realm of medical technology, a major focus must be maintained regarding patient safety and product quality. As leaders in the MedTech industry, it is imperative to put processes and systems in place to ensure vigilance around potential risks -- and proactively implement measures to address them. Sometimes, however, issues identified post-market result in product recalls.... Read More

When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultants are an excellent option. Choosing the right consultant can help your organization avoid compliance problems and improvethe time-to-market for your product. Read More

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

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

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

Many startups mistakenly believe that creating a successful QMS strategy means building complex solutions to satisfy all elements of ISO 9001:2015 (or similar systems). Such an approach can be overwhelming, time-consuming, and even counter-productive. Quality management systems should be tailored and scaled to the specific business needs. Read More

The saying "an ounce of prevention is worth a pound of cure" is especially applicablewhen talking about prevention vs. detection in quality control. Estimates show that it is ten times more costly to correct a problem than it is to prevent one. Poor qualitycan result in additional business costs such as lost customers, wasted materials, product recalls, reworking the product, and cost of... Read More

Your regulatory strategydetermines whether your 510(k) submission clears the FDA or dies on the vine. It is the deciding factor inhow 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

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, submissionscome with costs, which can be enormous depending on the type of regulatory filings. Read More