In an increasingly connected world, more countries look to protect their citizens through the development of their own medical device regulations. Large markets continue to shape and evolve their existing regulations, making requirements more nuanced and complex. Change in the global regulatory landscape is constant! As a result, it is challenging to keep on top of everything. New FDA guidance… Read More
QMS Audits Critical to Quality Improvement
One of the most powerful catalysts driving business improvement is the experience gained from QMS audits. Internal, customer, and certification audits are essential for any quality management strategy to succeed. They are a strong tool that can be used to more accurately define and track non-conformances by product or process, prioritizing them, and to provide valuable improvement recommendations to senior executive… Read More
Is Your Company Ready for the EU MDR Overhaul?
The EU Medical Device Regulation (EU MDR) requires more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Senior management should be involved in strategic planning for changes that… Read More
The Largest Medical Device Market in the World: Do You Need Help?
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. Coupled… Read More
A Lesson in the Importance of Premarket Approval
Recently, the FDA ordered that all sales and distribution of surgical mesh for transvaginal repairs be stopped. Both companies still selling the mesh have 10 days to submit plans to remove the mesh from the market. The ruling is the latest in a series of FDA actions targeting the escalating safety risks associated with the mesh. The FDA’s order garnered… Read More
FDA Announces Changes to 510(k) Process
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. In keeping with industry trends, a major factor cited for… Read More
At Home Diagnostic Equipment Poses Quality Challenges
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 Role of Vigilance in EU MDR
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
Unique Partnership Has Promise, Raises New Questions
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
Transitioning from ISO 9001 to 13485
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
