The medical field is continually evolving, and nowhere is that trend more evident than in the realm of medical devices. From wearable medical devices to increasingly smart data infrastructure, technology will take center-stage in 2021. At the same time, regulatory bodies like the US Food and Drug Administration (FDA) are developing new guidelines to manage the increased reliance on these... Read More
According to Johns Hopkins Bloomberg School of Public Health, clinical medical intervention trials that companies use to support FDA drug approvalscost approximately $19 million per trial. While this may only be one percent of the total cost of developing a new drug or other medical intervention, it means creating a low-quality clinical trial — or getting low-quality data from the endeavor — can... Read More
The importance of preparing high-quality regulatory documents should never be underestimated. Low quality or poorly written submission documents may lead to expensive delays or rejection of regulatory approvals that can result in launch delays, extra costs, and compliance risks. Typically, submissionscome with costs, which can be enormous depending on the type of regulatory filings. Read More
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, in... 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