MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate. As I am sure you are already aware, the new Article 97 basically allows…
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SwissMedic has raised a new FAQ
SwissMedic has raised a new FAQ document regarding the registration of Medical Devices on the Swiss Market. Some of the answers may surprise you! Download a copy here:- file:///C:/Users/Martin/AppData/Local/Temp/MicrosoftEdgeDownloads/e5949b5e-8c43-42a3-a550-46d2320cfd21/BW630_30_009e_MB_FAQ_Notifications.pdf
Did you know ISO/TR 24971
Did you know ISO/TR 24971, Medical devices β Guidance on the application of ISO 14971, is a companion document to the globally recognized risk management standard ISO 14971, Medical devices β Application of risk management to medical devices. The ISO standard, which was updated in…
How does the recent EU-proposed amendment to the MDR affect products sold in the UK?
How does the recent EU-proposed amendment to the MDR affect products sold in the UK? Over the past few months, we have provided updates regarding the proposed amendments to MDR Regulations (EU) 2017/745 and (EU) 2017/746 by the European Commission, which is now in effect.…
SAI-Approved SA8000 Auditor Course (16-20 November 2020)
International Associates Limitedβs will be running its fourth On-Line SAI-Approved SA8000 Introduction & Basic Auditor Course on 16-20 November 2020. The reception from participants was quite good as lockdowns in different countries across the world made it difficult ….
On-Line SAI-Approved SA8000 Auditor Course
International Associates Limited’s third On-Line SAI-Approved SA8000 Introduction & Basic Auditor Course will run on the 28 September-2 October 2020. Facing the challenge of the “new normal” brought by COVID-19 pandemic, International Associates has already conducted two on-line courses. The reception from participants was quite…
SAI-Approved SA8000 On-line Course
Since the first quarter of 2020 until now, we are facing a very challenging time due to COVID-19 pandemic, and all business sectors and industries are affected. The lockdowns in different countries across the world made it difficult for people to travel, do business, and…
OHSAS 18001 to ISO 45001 Migration
Due to the current Covid-19 pandemic and the challenges due to that, International Accreditation Forum (IAF) has given an extra 6 (six) month extension to the original migration deadline, which was 12 March 2021 but now ends on the 30 September 2021 for migration of…
ISO 13485 Medical Devices
For ISO 13485 Medical Devices Quality Management Systems, International Associates have just had a large extension to scope for Accreditation…
Association of Professional Social Compliance Auditors (APSCA)
The Association of Professional Social Compliance Auditors (APSCA) was created to enhance the professionalism, integrity and credibility…