In the run up to the UK exiting the European union on the 31st of December 2020, negotiations are occurring that will define the nature of the regulatory approval process required to sell medical devices and IVDs in Great Britain and Northern Ireland. The MDR and IVDR will fully apply in EU Member States from 26
As restrictions on work and movement are eased there will be an understandable desire to get back to work as soon as possible. However, the return to work will present new challenges, balancing the need to begin operations against the ongoing requirements to maintain social distancing and staff safety. It is a legal requirement to
In current circumstances one frequent question we are receiving is with regard to the effectiveness of remote auditing. Certification bodies without exception are continuing to complete their planned audits and are doing so in most circumstances with the aid of technology. Can they really be sure they have covered everything and can the results of
Our public training programme was suspended in March but we are now beginning to deliver a more comprehensive training programme. We will deliver our courses whilst maintaining all social distancing guidelines and will supply all our delegates with our COVID-19 risk assessment and special instructions to make training safe for all. If you have booked
A message from our Managing Director (Updated June 2020) QCS International is attempting to provide all our clients with a service as near as normal during the current situation. We are introducing measures to minimise risk and to find alternate ways of working so that you are able to maintain your management systems, health and
What do you need to do to migrate to ISO 45001? The new international standard for health and safety management, ISO 45001, was published in 2018. On issue those currently certified to OHSAS 18001 (the British Standard for health and safety) were given three years to complete arrangements to be certified to the new standard.
The European Commission (EC) has published a public notification which delays the Eudamed implementation date by 2 years to 26 May 2022. It was understood that Eudamed will be implemented in separate stages, however, the EC stated that it would only be possible to implement Eudamed once the entire system was developed and validated. It
This simple question is one we are frequently asked by our clients– just why should we seek certification and what benefits is it going to bring us? The answer to this will depend upon the organisation, how much effort will be required to gain certification and the commercial benefits that may be generated by being
David Evans, QCS International’s Information Security consultant, explains what ISO 27001 is in the context of recent legislative changes and those who have been caught out on the wrong side of these! What is ISO 27701? In short, it’s an information security management system, which if applied correctly could save an organisation a great deal
The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes, this requirement applies to all devices apart from custom-made and investigational devices. UDI Structure The product specific UDI is comprised of