For those of you visiting MEDICA in Dusseldorf on November 12th to 15th you will find John Adcock and Farhaan Shaikh available to meet face to face on both Thursday and Friday. This is a big opportunity to network so let us know early if you will be there so we can arrange to get … Read more
Quality Management System In relation to the Quality Management System [QMS] the OBL will be expected to maintain a QMS which covers the requirements as defined in the Medical Device Directive or IVD Directive as relevant. This does not mean that a fully compliant ISO13485 system must be in place although if this is the … Read more
OBL Guidance to Clients This article is now obsolete and has been replaced by our article on Virtual Manufacturing, which has replaced OBL. Press here to be redirected. As you are probably aware there have been significant changes to the requirements of Own Brand Labelling [OBL] in relation to the MDD 93/42/EEC and IVDD 98/79/EC contained … Read more
SGS Notified Body presented a very interesting Webinar on November 13th (some of you may have been joining in) and this presentation was repeated again during the MEDICA show in Düsseldorf. The story remains unchanged with Notified Bodies making it very clear that from January 2014 the audit processes will be changing for all manufacturers … Read more
Training and managing personnel information plays a vital role in the success of a quality management system. Once trained and skilled, your employees not only ensure the quality of products and services delivered but also work to ensure that the organisation is compliant with industry regulations. This simple ACTIV web-based application was designed so that … Read more
The day before the European Parliament was scheduled to vote on adopting a more FDA-style method of medical device regulation, the central European consumer organization issued a video of medical device horror story testimonials, particularly relating to breast implants. This has not helped industry to fight to avoid radical changes. We (industry) all know that … Read more
All of the following points should be considered in relation to the new legislation: a). There is a high emphasis on the need to audit the premises of the (legal) manufacturer and also critical subcontractors and suppliers. This will lead to the need to visit all manufacturers annually including own brand labellers and to increased … Read more
Here at, Advena Medical Ltd, we firmly believe that a smooth transition to a digital – paperless document workflow can set up an organisation for success, which is why we’ve developed an in-depth QMS System called ACTIV to assist our partners as they make the switch. We have noticed that more and more organisations are switching … Read more
It is obvious that test laboratories are getting totally bogged down with the testing to EN ISO 60601-1 3rd edition. We recently got a message from Intertek that they could not take on any more EN ISO 60601-1 3rd edition testing as the risk management phase was taking too long and they did not have … Read more
The Notified Bodies around the world are preparing themselves for the new upcoming MDD regulations recast. The regulation was published on 26th September 2012 includes the new EU regulations on all medical devices. The final regulation is likely to be released in 2014. The changes would reflect: v The new EU regulation structure and system … Read more
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