There is a growing need in the current global economy to outsource with no foreseeable turning back. Medical Device and In Vitro Diagnostic Manufacturers in the United States are in constant need to tap in new markets (Europe with CE marking, Canada with CMDCAS and soon Japan, Brazil and Australia with MDSAP), increase ability to respond to opportunities/demand and concentrate their efforts on innovation. Without the concept of outsourcing supply chain links, the medical device market would be in slow motion and startups will struggle to exist.
On March 1st, 2016, the latest revision of ISO 13485, the internationally recognized Quality Management Systems standard for the medical device industry was officially published. ISO 13485:2016 is now here and ready to take over ISO 13485: 2003.
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.