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...
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...
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,...
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...
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.
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...
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...
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...
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...
If you are currently selling or are looking to sell a medical device in Europe, you should have heard about the big industry news: the European Union has officially repealed the Medical Devices Direct [MDD, 93/42/EEC] and the Active Implantable Medical Device Directive [AIMDD, 90/385/EEC] and replaced it with the M...
