The Medpoint Blog

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Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.
What is Regulatory Strategy?

What is Regulatory Strategy?

Developing an effective regulatory strategy is more than following the step-by-step requirements outlined by a regulatory agency. It's a proactive process that helps you refine your product development goals and get your product to market faster. With the help of an experienced regulatory strategist, you can create a plan that addresses potential competitors, various regulatory requirements at... Read More

5 Ways to Improve Your Document Control System

5 Ways to Improve Your Document Control System

Quality managers everywhere will attest to the fact that effective document control is critical to the quality management systems — a process that is central to any regulated organization. And depending on just how efficiently document control is done, it can either make or break the company.  Read More

What is your QMS Strategy?

What is your QMS Strategy?

Many startups mistakenly believe that creating a successful QMS strategy means building complex solutions to satisfy all elements of ISO 9001:2015 (or similar systems). Such an approach can be overwhelming, time-consuming, and even counter-productive. Quality management systems should be tailored and scaled to the specific business needs.    Read More

Prevention vs Detection in Quality Control

Prevention vs Detection in Quality Control

The saying "an ounce of prevention is worth a pound of cure" is especially applicable when talking about prevention vs. detection in quality control. Estimates show that it is ten times more costly to correct a problem than it is to prevent one. Poor quality can result in additional business costs such as lost customers, wasted materials, product recalls, reworking the product, and cost of... Read More

5 Regulatory Tactics to Improve 510(k) Clearance Results

5 Regulatory Tactics to Improve 510(k) Clearance Results

Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vine. It is the deciding factor in how long clearance takes: from 90 days to over six months. Lost months mean lost revenue and re-tasking resources that could be spent on other revenue-generating activities.  Read More

6 Best Practices in Regulatory Writing

6 Best Practices in Regulatory Writing

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, submissions come with costs, which can be enormous depending on the type of regulatory filings.  Read More

How to Make Your QMS More Efficient

How to Make Your QMS More Efficient

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

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