In 2012, The International Medical Device Regulators Forum (IMDRF) recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. It was at that point that the concept for the Medical Device Single Audit Program (MDSAP) was introduced.
Over the past 3 years and into 2016 significant progress has been made towards the full realization of the MDSAP program including the MDSAP Pilot Program which started January 1, 2014 and is expected to continue until end of December 2016.
With over one million certified companies over the world, the international quality management systems standards ISO 9001 and ISO 13485 are among the most commonly used today.
News of different mergers and acquisitions have dominated the international medical device landscape for the previous couple years. As the industry responds to different regulatory and business concerns throughout the world.
While the Medical Devices Regulations are making their way through the European legislative process, it may be good times for medical device manufacturers that sell their devices within Europe take a closer look at the proposed regulations. This past June 19, 2015, the EU Council published their proposed revisions to the proposed regulations governing medical devices and IVDs in Europe.
The differences among the international in vitro diagnostic (or IVD) medical device regulatory schemes can be confusing, especially when one jurisdiction views a device differently than another. It’s important to stay within the lines of the jurisdiction’s regulation and definitions of what it considers to be an IVD.
The Russian medical device market can be a smart move for medical device manufacturers. Between the size of the market and the low saturation of imports on the market, some medical device manufacturers may find that it is worth the additional regulatory approval to sell their devices in Russia.
Stolen data, intrusion, industrial espionage, piracy, leaks, phishing, malware, and others: the threats undermining the information safety and security are numerous. They are also proven to be a serious threat for the company’s partners, clients, and end consumers. A real scourge, cybercrime can therefore strongly impact the business’ performance and represents a major economic challenge.
In September 2013, the EU Commission published Recommendation 2013/473/EU, which details some requirements for notified bodies when performing the systematic unannounced audits. One of these requirements is to sample products at various stages of their production and test them to ensure their compliance.
The path to market approval for a medical device in the EU is no simple decision for a manufacturer to make. The Medical Devices Directive, for almost every device class, gives manufacturers a choice as to which conformity assessment they would like to use.