The medical device and pharmaceutical quality industry is constantly changing, as evidenced by recent quality and regulatory updates. Revisions to ISO 9001 and ISO 13485, major changes associated with MDSAP and EU MDR, and new expectations in some areas for additive manufacturing have made staying on top of what’s going on in our ever-changing industry harder than ever. As technology… Read More

Medical device standards and regulations have changed significantly in recent years, but one of the biggest changes to be released is the pending transition of the Medical Device Directive to the Medical Device Regulation. This update will have widespread industry impact, some of which is not yet fully understood. Some changes are minor and designed to align to other existing… Read More

With updates to the ISO 17025 standard released in 2017, now is a great time to review some of the changes that we have seen come through, and what updates may be required to maintain compliance to the standard. While there were a number of alterations, there are three key areas to note. Newly Designed Process Approach The general focus… Read More

While there were some minor changes regarding Management Responsibility in the latest revision to ISO 13485, the expectations for top management commitment remain as important as ever. The active involvement of top management is crucial to ensuring the continued relevance and success of your company’s Quality Management System. Whether you are new to management responsibilities or have been handling them… Read More

The quality community received a sobering reminder recently of the importance of their work when Southwest Airlines flight 1380 had an engine suddenly explode soon after takeoff. While the pilot was able to safely land the crippled plane, there was one passenger fatality – the first on a United States airline since 2009. There will of course be a detailed… Read More

Product recalls are an unfortunate part of any manufacturing industry. For medical devices and pharmaceuticals, recalls are serious affairs requiring swift corrective action. Each year, an average of 4,500 drugs and devices are removed from the market due to recall. In 2017, the FDA identified more than 30 Class I recalls, where further use of the product could result in… Read More

A robust quality management system (QMS) is important to every company, but just as no two companies are the same, no two quality management systems can be identical either. It is important to ensure that the system you develop serves the needs of your company specifically, improving operations and mitigating risk, not just fulfilling quality requirements. Whether you are building… Read More

You depend on your suppliers to provide quality products, but each supplier represents a risk. If you are registered to 21 CFR 820, there are strict FDA guidelines in place governing expectations for supplier controls. Medpoint offers several services to help you prepare for an FDA audit and avoid the time and expense of responding to FDA findings that drain… Read More

Among emerging markets in the medical device industry, China stands apart for its exceptionally rapid growth. From 2004 to 2014, healthcare spending in China has expanded from $90.8 billion to just over $590 billion. With FDA News declaring recently that opportunities in China are “better than ever,” major medical device manufacturers are scrambling to carve out their space in the burgeoning… Read More