April 25, 2020

Link to the Policy Document: https://www.fda.gov/media/136939/download

The FDA recently put out a new enforcement policy for digital health devices treating psychiatric disorders during the COVID-19 Public Health Emergency. Release of the policy is intended to help expand the availability of digital health therapeutic dev...

September 6, 2019

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems.

You will find this podcast helpful for understanding changes imposed on SaMD under new EU MDR. SaMD manufacturer will find this podcast helpful for clarifications on qualification and classification changes on SaMD, and action items to...

July 24, 2019

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...

July 18, 2019

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,...

July 18, 2019

             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...

June 5, 2019

You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020. 

Link to the Article: https://www.greenlight.guru/blog/qms-eu-mdr

The European Medical Device Regulation (EU MDR) has been created to r...

May 29, 2019

        Currently, we are witnessing a drastic regulatory shift as MDR (2017/745/EU) replaces MDD (93/42/EEC) and AIMDD (90/385/EEC), effective May 26th, 2020. As a result, some Software as a Medical Device (SaMD) companies who already have introduced devices on the market might be subject to more stringen...

May 3, 2019

This webinar was hosted by Kyle Rose, President of Rook Quality Systems.

You will find this webinar helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020. 

The in-depth webinar will cover some of the most import...

December 13, 2018

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems.

You will find this podcast helpful for understanding how Rook helps SaMD companies ensure that their documentation, platform, and systems they establish during the design, development, and manufacturing of software aligns with regulato...

December 13, 2018

This webinar was hosted by Kyle Rose, the President of Rook Quality Systems.

You will find this webinar helpful for understanding purchasing and supplier control process detailed in the ISO 13485/ 21 CFR820/ MDSAP/ MDR regulation. Specifically this webinar will cover: 

- Upcoming changes in ISO 13485 and 21 CFR 820 to mee...

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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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