The Medpoint Blog

Medpoint
Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.

Medpoint Welcomes Europe-Based Technical Business Development Consultant

Read More

Maintaining Your Supplier Controls During the COVID-19 Pandemic

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

Are You Getting the Regulatory Support Your Company Needs?

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

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... 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. 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.  Read More

A Lesson in the Importance of Premarket Approval

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

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.  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 and has been the subject of... Read More