The Most Important Compliance Best Practices You Need to Know

A successful 510(k) application is important for medical device companies to reduce burdens of cost, time, multiple inspections and faster regulatory clearance. This white paper provides information about classification of medical devices, important sections of the application, content not to be missed in documentation and other best practices to be followed to compile and submit a 510(k) for successful approval.

The EU regulates medical devices with the EU Medical Device Directives. The core concern of these devices is safety of the end user and the regulations have been formulated keeping this in mind. The complexity of the EU, a body with 27 member states,necessitates unique regulatory requirements that device importers or foreign manufacturers have to be aware of in order to achieve compliance. This white paper discusses six key elements that will help manufacturers ensure compliance with the EU Directives and avoid the unnecessary costs and confusion that can result due to misunderstanding the regulatory processes.

As the market for medical devices in China grows, the country is increasing its regulatory scrutiny of products being sold to consumers. The regulations governing device registration, marketing,safety and vigilance are especially strict and manufacturers can land into the legal hot water if they don’t comply with the law. This white paper discusses six best practices (registration,marketing authorization, instructions for use, labeling, device advertising rules, device safety) that are vital for manufacturers to ensure they are in compliance with medical device registration, marketing and safety rules in China.

Inadequate design controls continue to be highlighted by the FDA as a major reason for warning letters issued to medical device companies. Manufacturers who have lax controls over design and development of devices also have to recall products as they may endanger user safety. Such actions have a negative impact not just on company profit margins, but also reputation and public trust. This white paper discusses six best practices that medical device manufacturers should follow in order to devise and implement design controls that are compliant, adequate and help in making products that are safe and effective.

The FDA strictly regulates the import of medical devices into the United States. It has detailed regulatory requirements for foreign medical device manufacturers that should be followed if imported devices are to be sold in the US market. Non-compliance with these rules can result in detention of products at ports of entry, unnecessary expenses involved in paperwork, queries and hearing and a loss of revenue for the importer. This white paper provides five best practices that both foreign medical device manufacturers and importers in the US can follow in order to ensure that the device import process is quick and efficient.

In this article, Haroon Atchia, CEO & Technical Director of Quality First International provides a critical examination of the European Commission's update of MEDDEV 2.12/2 entitled Post Market Clinical Follow-Up Studies, a guide for Manufacturers and Notified Bodies, published in January 2012.

The Department of Justice (DOJ) and the Securities & Exchange Commission (SEC) accused the parent company (Smith & Nephew PLC, a global medical devices and products company headquartered in London) and its US and German subsidiaries of violating the provisions of the Foreign Corrupt Practices Act (FCPA).

Automation often seems the best choice for medical device manufacturers in order to ensure that variations in processes are avoided and quality consistency is attained. However, automating blindly comes with high risks and therefore a number of steps must be taken to avoid such risks. In this article, Dev Raheja, a medical device quality expert, explains the risk management principles and processes that must be taken into consideration before implementing manufacturing automation.

Several surveys conducted in 2009 showed that around 61% of American adults get their health information from the internet. Around 79% of patients also believe that they learn more about medicines from the manufacturers’ social media channels.

This uptick in numbers of people who use the internet for more information on regulated products has forced the FDA to address the issue of using social media and the internet to disseminate information on regulated products.
 

According to the Securities and Exchange Commission (SEC), Biomet Inc violated the provisions of the Foreign Corrupt Practices Act (FCPA). The violation occurred in the form of bribes that Biomet’s subsidiaries and their agents paid to public doctors in Argentina, Brazil and China for almost a decade in order to bag business.

This article details the allegations against Biomet and the compliance best practices that have to be followed to avoid similar charges.

How can various departments work together to ensure medical device design projects are executed efficiently and successfully? This responsibilitiy lies with the management - but what are the best practices that can be followed?

Dev Raheja, a renowned medical device quality expert, explains all in this article.

There are over a 1000 recalls of medical devices annually. What are the dangers that make medical devices harmful to the user? Dev Raheja, a renowned medical device quality expert, explains the types of dangers in medical devices in this article.

Can the Swiss Cheese Model be used to create medical devices that are safe and reliable?

Dev Raheja, a medical device quality expert, explains how this model offers a highly effective approach in understanding and preventing adverse events in medical devices.

Usually Quality Assurance (QA) is looked upon as bearers of bad news. Then it is forced react with the CAPA (Corrective and Preventive Action) system which is always reactive. Instead, QA can be the bearers of good news by reporting which adverse events were proactively prevented by eliminating their root causes. This article, by renowned medical devices expert Dev Raheja, details the ways this can be achieved.

The FDA requires medical device manufacturers to submit reports in case of device malfunctioning. But when and how are these reports to be submitted? Which medical device malfunctions require reporting to the FDA?

This article describes the best practices that medical device manufacturers can follow in order to comply with medical device reporting to the FDA.

The FDA has issued guidance on how to submit 510(k)s for changes to existing devices. This guidance details the types of significant changes that necessitate the need for submitting a 510(k).

This article describes the best practices that medical device manufacturers can follow in order to comply with this guidance.

ISO 14971(Application of Risk Management to Medical Devices) recommends using Preliminary Hazard Analysis (PHA) as an important tool for risk control. PHA is an analysis at macro level.

In this article, medical device expert Dev Raheja describes the best practices to be followed when conducting Preliminary Hazard Analysis when manufacturing devices.

Medical device recalls happen frequently due to faulty device design or usability. How can medical device manufacturers prevent medical device recalls? What are the best practices to be followed?

In this article, Dev Raheja, a recognized expert on medical devices, discusses the various kinds of recalls, how the FDA oversees these and how to prevent them.

IEC 80001 is an international standard for managing risks in IT networks using medical devices. Its aim is address issues of safety, effectiveness, data, and system security in the network. The standard defines the process and also defines responsibilities for each of the stakeholders involved. It recognizes that risk management should be applied throughout the lifecycle of the networks. 

This article discusses the best practices for medical device manufacturers to comply with this standard.

The Food and Drug Administration (FDA) receives spontaneous adverse event reports from health care professionals and consumers. A manufacturer, upon receiving an adverse event report from a patient or health care professional, has to send a report to FDA.  The U.S. Department of Health and Human Services (HHS) Food and Drug Administration Center for Biologics Evaluation and Research (CBER) has mandated reporting of adverse events and has issued guidance towards this end.

This article describes the best practices to be followed in the reporting of adverse events.