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

Medical devices undergo a strict and rigorous evaluation by the Food & Drug Administration (FDA) to obtain approval for the US market. Suppose you want a Class II medical device cleared for sale in America. In that case, you need to be familiar with predicate devices (predicates) and how to support your substantial equivalency claims with carefully crafted documentation. 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

Maintaining oversight and control of your supply chainis a critical part of your organization's quality management system. Effective and efficient supplier audits can have significant impact on long-termcompliance profile andprofitability. 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 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

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 tomonitor 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 thesupplier... 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 industriescanbest 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