The Medpoint Blog

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

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

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 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

Risk Management in EU MDR

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

Prepare Your Organization for Medical Device Single Audit Program (MDSAP)

Is your business challenged by a complex and ever changing global regulatory environment? Medpoint can help! Read More