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ISO 13485:2016 Success!

Advena Medical have chalked up a remarkable success, and at the first time of asking!

Having read and understood the requirements of this new edition of the QMS standard. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our client, the result of which, after a 3 day audit by LRQA, one of the UK’s most respected Notified Bodies, was a glowing report and more importantly our client achieve the much converted certification it needed to move its business forward. This is sure to be the first of many ISO 13485:2016 success stories.

If you’re looking to transition to ISO 13485:2016 please contact us for more details and become part of a success story.

Email Advena: info@advenamedical.com

Gap Analysis to the new Medical Device Regulation EU 2017/745 (MDR)

This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now!

Manufacturers across the world are not only planning to transition to the MDR they are also transitioning to the new QMS standard ISO13485:2016, which must be completed in 2019. Notified Bodies are already quoting extended lead times due to shortages of staff and other operational issues, it makes sense therefore to commence your planning process, don’t get caught out!

With our team of experts Advena can help and guide you through the transition process from MDD to MDR.

Our comprehensive MDR gap analysis, reviewing your current technical file, will highlight gaps, deficiencies or non-compliances in your documentation and processes, this will be presented via our in-depth gap analysis report, with suggestions and recommendations on how to fix these in readiness for your first MDR audit.

For more details please contact our team: info@advenamedical.com

Product Liability Insurance: MDR / IVDR

Advena Ltd. have now identified an insurer who will accept the risks of product liability insurance in accordance with the new regulations, needless to say for Advena as an EU Authorised Representative the premiums will increase significantly, several thousands of pounds higher than previously.

The good news is we will be able to continue to offer our EU Authorised Representative service under the new regulations.

In addition the insurance provider we have identified is willing to discuss with our clients their own insurance provision, should any client be interested in exploring this option please email Advena in the first instance, so we can make the initial introduction.

Breaking News – The New Regulation on Medical Devices (MDR) and Regulation on In-Vitro Diagnostic Medical Devices (IVDR) are now Published

On 5th May 2017 the new Regulation on medical devices (EU 2017/745) and a Regulation on in-vitro diagnostic medical devices (EU 2017/746) were published, these replace the existing Directives.

These new rules will only apply after a transitional period, 3 years after entry into force for the Regulation on medical devices and 5 years after entry into force for the Regulation on in-vitro diagnostic medical devices.

With these new Regulations the burden of responsibility increases on all commercial entities, especially EU Authorised Representatives such as Advena, therefore the times ahead are expected to be challenging for all concerned.

Advena with our team of experts and range of services are well placed to help and advise clients through the applicable transitional period.

Meet Advena at Arab Health 2017

Advena will be located in Za’abeel Hall 4, Stand Z4 E40 at this important show in Dubai from 30th January to 2nd February 2017.

We will be available to meet clients old and new during this trade show and have access to meeting room facilities at the ABHI UK Pavilion. We advise those who would like to meet one of our team to contact Anthony Kirby (Anthony.kirby@advenamedical.com) well in advance as the meeting room needs to be booked for any extended conversations or product reviews.

Further details about Arab Health 2017 may be found at http://www.arabhealthonline.com/

Anthony Kirby
Business Manager
Kenneth Shaw
Regulatory Associate
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