The growth in popularity of at-home medical device diagnostic equipment has obvious benefits for consumers, but it has not come without risks. The well-publicized story of Theranos, a health technology corporation, and the deception involved in the company’s rapid explosion from unknown startup to a business valued at more than $9 billion has unfortunately cast doubt on this market’s future… Read More

The transition from EU MDD (2007) to EU MDR (2017) has included an increase in expectations for medical device companies in several areas. One of the key areas of intensified focus is that of vigilance, which now more clearly defined and separated from Post Market Surveillance (PMS) activities. While Post Mark Surveillance is an important part of any quality program… Read More

Earlier this summer, Glaxo Smith Kline announced a partnership with popular take-home DNA kit company 23andMe. The deal, which gives GSK four years of exclusive rights to 23andMe data for purposes of drug development, could very well usher in a new era of pharmaceutical research. GSK has gone all-in on this idea, investing $300 million in 23andMe in what is… Read More

With the recent updates to ISO 9001: 2015 and ISO 13485: 2016, many companies are now beginning to review which standard is most applicable to their business. ISO 9001 is generally the more applicable standard designed to guide any quality management system regardless of industry or business type. ISO 13485 is specifically targeted towards companies involved in the design, manufacturing,… Read More

Risk management has been getting a great deal of attention in the medical device industry recently, in part due to the increased focus on it in the new 2017 EU MDR. Where the 2007 EU MDD was intentionally written somewhat vaguely, to be interpreted and applied as best determined by individual companies, the 2017 MDR language is much more specific…. Read More

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