Regulatory & Safety Experts for Global Medical Device Approvals
Please note as of 6 May 2022 you will no longer be able to contact us at: 3331 SW Seymour StreetPortland, Oregon 97239 We’ll be disconnecting our office phone line (503) 244-6151 permanently “cutting the cord”. Use the cell number
On December 20, 2021 the FDA Released their Recognition List Number 057 through their online db. With that publication of list 057 two, EMC IVD standards were added to the list. But the FDA only Partially Recognized IEC 61326-1:2020 and
2 February 2022 On 1 February 2022 the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market. The UKNI mark
Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world
The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746on 5 January 2022 and 7 January 2022 amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195 all above references are
