Increasing the efficiency of your Quality Management System (QMS) should be a no-brainer. When you invest in an efficient QMS, you discover new growth opportunities, improve customer satisfaction, and gain a competitive edge. Improving the efficiency of your QMS can help you achieve business and quality management goals. Read More
When you need an industry expert's advanced skills on an occasional or temporary basis, sometimes it may make more sense to contract with them, rather than hire them as full-time employees. Read More
Maintaining Your Supplier Controls During the COVID-19Pandemic Every year Medpoint consultants conduct hundreds of supplieraudits around the globe for our medical device, pharmaceutical, and biotech clients. These audits are conducted by our certified auditors, generally on-site at supplier locations, to evaluate compliance with quality management system standards and regulations. However,... Read More
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! Read More
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... Read More
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. Read More
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