Understanding IEC/ISO 62304 and FDA Requirements for Medical Device Software Development Life Cycle (SDLC) Management

Medical device manufacturers often hit roadblocks during FDA inspections or when it comes time to submit a 510(k) application for their device. Regardless of whether your device is considered software as a medical device (standalone SaMD) or software in a medical device (SiMD), there are specific steps that must be taken regarding change and risk management from the earliest stages of development to avoid running afoul of FDA requirements with respect to medical devices’ software development life cycle (SDLC). It […]

Which EU Notified Bodies Are “Designated” Under the MDR 2017/745 and IVDR 2017/746?

UPDATED May 7, 2022 Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. There is no current list of Notified Bodies seeking designation but some have indicated their intent on their website and we have added them in the pending list below. As Notified Bodies are officially designated, we will add them here. Help us keep this information up to date. Email us with corrections or additions. YES! EU Notified […]

Supplementing Your Medical Device PMS Efforts with Online Data

Blogs. Social media. Online forums. Product reviews. While postmarket clinical follow-up (PMCF) studies, user surveys, clinical registry studies, electronic health records, and insurance claims data are all important sources of proactive data, most complaints will never cross your desk. Instead, users will often take to online forums and social media to voice their concerns. These potential sources of postmarket surveillance (PMS) data are probably not high on your priority list. After all, trying to extract relevant and actionable PMS data […]

The Medical Device Single Audit Program (MDSAP): Your Questions Answered

Regulators from five countries (US, Canada, Australia, Brazil, and Japan) joined forces in 2012 with the goal of coordinating data gathering and reducing redundant audits for medical device manufacturers. The program has grown quickly. Health Canada led the way and required MDSAP certification starting in January 2019. At Oriel STAT A MATRIX we get many questions about MDSAP, so we have compiled a list of the most common ones. Questions and responses are grouped into the following categories. Who Needs […]

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All Topics, Auditing, MDSAP

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