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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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Documentation impacted by EU MDR

For medical device companies selling in the EU, the May 2020 deadline for Europe’s new Medical Device Regulation 2017/745 (MDR) is coming up soon. Post this date, non-compliant companies will lose their CE-mark certification and the right to sell to the European market. Compared to the MDD, the MDR 2017/745 takes a more life-cycle approach that is very similar to the one advocated by the FDA. The regulations feature several significant changes including new regulations associated with Vigilance and Post-Market Surveillance, Scope and Classification of Products, Changes affecting Notified Bodies, Unique Device Identification (UDI), changes in Safety and Performance Requirements, Person Respon

How do startups leverage FDA's Pre-Cert Working Model - Part 2

This is Part 2 of a two-part series focusing on FDA's Pre-Cert Working model. 4. Streamlined Review: It is expected that software products that are considered for Streamlined Review are from organizations that have gone through excellence Appraisal, and thus these have demonstrated excellence in developing, testing, maintaining, and improving software products. The streamlined review process is intended to identify what information would be reviewed, how modifications affect marketing authorization, and risk management established per device’s intended use and the SaMD’s clinical evaluation results (i.e. N41, SaMD Clinical Evaluation). The process would work as follows: a) Understand the pro

How do startups leverage FDA's Pre-Cert Working Model - Part 1

The Pre-Cert program represents a new regulatory paradigm for FDA regulating future software as medical device (SaMD). To cope with shorter development cycles and unique opportunities that software products offer (i.e. address malfunctions quickly to reduce adverse events), the FDA intends to certify organizations by their proposed culture of quality and organization excellence (CQOE) and past level of experience with software design, testing, and monitoring. Depending on the type of certification an organization receives and the risk profile of the software, a suitable approach for carrying out premarket review will be determined. This allows the FDA to work with these pre-certified organiz

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