Many of my clients are beginning to investigate whether joining the Medical Device Single Audit Program (MDSAP) is a good fit for their organisation. The program allows an MDSAP recognized Auditing Organization (AO) to conduct a single regulatory audit …More Details
Many of my interactions with clients begin when they contact me wishing to gain CE Mark approval for their device to allow them to sell the product into the European Economic Area (EEA). We generally begin with high-level training to support their unde …More Details
In order to ensure that medical devices distributed to the market remain safe and perform as intended, adverse events or incidents are reported to the appropriate Regulatory Authorities. In Europe, this system is known as the vigilance system. In the U …More Details
Support related to clinical investigation planning and execution for the EU and US markets is a common client request. The first step every medical device organisation must take is to determine whether a clinical investigation (sometimes referred to as …More Details
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If you are a medical device innovator who demands excellence, then contact Neasa Greene Consulting today for an initial consultation.