Notified Bodies seem to be placing greater scrutiny on medical device manufacturers who have appointed an EU Authorised Representative (EC REP) with particular reference to unannounced audits. As many of you may already know, Notified Bodies now consider the EC REP a critical subcontractor and are therefore subject to an unannounced audit by the manufacturer’s … Read more
As many of you will already know, the requirements regarding Post Market Clinical follow up and Post Market Surveillance have increased dramatically in recent years. This is not only a result of the changes made within MEDDEV 2.7/1 Rev 4 June 2016 but also Clause 8.2.1 and 8.2.3 of ISO 13485: 2016, and in addition … Read more
ISO13485:2016 is the most recent version of quality management system (QMS), specifically for medical device manufacturers and is now considered the ‘gold’ standard. Manufacturers have until March 2019 in order to update their current ISO13485 QMS to this latest version and become certified. In addition if it’s your intension is to access USA, Brazilian, Japanese, … Read more
The Post-Market Clinical Follow-up (PMCF) is a post market activity which should form part of a manufacturer’s PMS plan. It consists of proactively collecting and evaluating clinical data related to the use of a CE marked device already on the market. The aim of the PMCF is to confirm the safety and performance of the … Read more
As a medical device regulatory and quality management (QMS) consultancy we place considerable value in holding our own ISO13485:2016 certified QMS. We are therefore pleased to announce receipt of our new ISO13485:2016 certificate covering the following scope ‘European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers’. Having … Read more
This month we welcome Richard Bassett to our team at Advena Limited., as our newest Senior Regulatory Consultant and QMS expert. Some of you will already know Richard as he is joining us from a well-known major UK Notified Body where he has been a Client Manager and Lead Auditor. This has included working as … Read more
This month we welcome Dr Andrew Whitton to our team at Advena Medical Ltd., as a Senior Regulatory Consultant. Andrew brings a broad wealth of knowledge and experience in medical device regulatory having previously worked in a number of senior regulatory roles and with many devices including IVDs, combination products, cardiovascular and wound-care devices, across … Read more
Following an intense 3 day ISO13485 transition audit we are pleased to announce Advena Limited & Advena Medical Limited have been recommended for ISO13485:2016 certification. This remarkable achievement is all the more impressive as it included a transfer from BSI to LRQA. Underpinning our ability to offer QMS consultancy to medical device manufacturers worldwide. If … Read more
Over the years we have expanded our comprehensive European Authorised Representative services to many non-EU manufacturers who have traditionally used EU importers and distributors for this role. Now, and particularly with the new EU device regulations looming that require data sharing, perhaps the time may be now to ask the question; “Can you trust your … Read more
There has been a lot of uncertainly about how Brexit is going to affect medical device manufacturers in the UK. Here at Advena we track the UK political news closely and feel now that unless there is significant shift in Westminster a “hard” Brexit may be almost inevitable. This is emphasised by the UK Notified … Read more
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