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Welcome to our Library of Regulatory, Certification Information and Updates in the Medical Device Area

Impact of Critical Suppliers and Subcontractors on Medical Device Market ApprovalsThere 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.

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MDSAP Prepare the transition for medical devices, canada, usa, brazil, japan, australia

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.

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Medical Device Reclassification in the Medical Device Regulation ProposalWhile 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.

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IVD and Borderline Medical DevicesThe 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. 

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MDSAP Prepare the transition, worldwide market access

clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Certification Project Manager - In Vitro Diagnostics responsible for medical device manufacturing clients.