The United States of America is the largest medical device market in the world. A population’s age is a good indicator of how high the need for medical devices will be in the coming years. As the United States’ “Baby Boom” population(those born in the years 1946-1964) continues to age, the medical market is projected to steadily increase. Read More

Recently, the FDA ordered that all sales and distribution ofsurgical mesh for transvaginal repairs be stopped. Both companies still sellingthe mesh have 10 days to submit plans to remove the mesh from the market. Theruling is the latest in a series of FDA actions targeting the escalating safetyrisks associated with the mesh. The FDA’s order garnered mass attention nationwidein large part because... Read More

The last several years have brought many changes to the medical device quality and regulatory industries, and recent FDA announcements promise even more in the near future. As announced in late November 2018, there are significant updates planned for the 510(k) submission process, specifically related to the use of predicates. Read More

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 and has been the subject of... 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 being called a separate agreement. 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, or... 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 and markets... 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 procedures, while... Read More