The Medpoint Blog

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Learn best practices and gain new insights on quality assurance, regulatory strategy, and clinical affairs.
How to Compare Regulatory Consultants

How to Compare Regulatory Consultants

When it comes to ensuring compliance and avoiding FDA warning letters, regulatory affairs consultants are an excellent option. Choosing the right consultant can help your organization avoid compliance problems and improve the time-to-market for your product.   Read More

Management’s Role in Developing a cGMP-compliant QS

Management’s Role in Developing a cGMP-compliant QS

Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key to setting up and maintaining a robust QS.  Read More

5 Labeling Changes that Require a New 510(k)

5 Labeling Changes that Require a New 510(k)

Medical device labeling changes are made for a wide array of reasons. When a manufacturer makes changes to the labeling for a medical device, they must assess the impact of the change against their 510(k) clearance.  Some changes may require a new 510(k) submission.  Others don't require a new 510(k) submission but will require thorough documentation of the changes.   Read More

How to Optimize Your CAPA Escalation Process

How to Optimize Your CAPA Escalation Process

In 2020, the most common reason for FDA's 483 observation letters was "procedures for corrective and preventative actions have not been [adequately] established." (1)  Read More

How to Evaluate and Select Quality Auditors

How to Evaluate and Select Quality Auditors

The key to a successful quality audit is selecting a highly qualified auditor. Since the quality of your organizational processes directly depends on the audit's effectiveness, it's imperative to choose the right professionals for the job.  Read More

What does the FDA Consider Data Integrity and Why Does It Matter

What does the FDA Consider Data Integrity and Why Does It Matter

For FDA (U.S. Food and Drug Administration)-regulated industries, organizations, and projects, the importance of data integrity is extremely high. Besides being a requirement for compliance reasons, data integrity is the foundation of a top-notch quality management system and paramount for ensuring patient safety.  Read More

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

5 Reasons to Seek External Auditors for your QMS

5 Reasons to Seek External Auditors for your QMS

Regular internal audits are a vital part of QMS maintenance and are in many cases a regulatory requirement. By collecting evidence and evaluating it objectively, a company can determine how well its quality management system is performing, and support an environment of continuous improvement.  An effective audit can identify areas of risk and opportunity. Even if the audit doesn't reveal any... Read More

How to Ensure Effectiveness of Internal Audits

How to Ensure Effectiveness of Internal Audits

Many executives only see internal audits as something that has to be done for compliance reasons. However, the reality is that an efficient and effective internal audit program can reduce redundancies, reduce risk, enhance customer satisfaction, and bring about cost savings. An effective internal audit will also improve efficiencies by identifying opportunities for improvement and eliminating... Read More