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ISO 13485:2016 Success For Advena Ltd in Malta!

Advena Limited,  Malta have chalked up a remarkable success!

Following the successful re-certification audit at our UK office at the end of February 2019, the next task was to audit our office in Malta (an EU27 member state) for inclusion on our ISO 13485:2016 certification. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our Maltese team, the result of which, after a gruelling audit by LRQA, one of the UK’s most respected Notified Bodies, was a glowing report and more importantly achieving the much converted certification it needed to move its EU Authorised Representative (EC REP) business forward.

If you’re looking for an EC REP based in the EU27 or are looking for QMS consultancy to ISO 13485:2016 please contact us for more details and become part of a success story.

Email Advena: info@advenamedical.com

 

Meet Advena at Arab Health 2019

Advena will be located in Za’abeel Hall 4, Stand Z4 J43 at this important show in Dubai from 28th to 31st January 2019.

We will be available to meet existing and prospective clients during this trade show.

We advise those who would like to meet one of our team to email for an appointment (info@advenamedical.com) well in advance to ensure we are available.

At this show the following Advena team members will be in attendance:

Anthony Kirby: Managing Director (Advena Malta)

Kirsty Ostle: Managing Director (Advena UK)

Kenneth Shaw: Regulatory Consultant (Advena Malta)

 

If you are planning to visit Advena at Arab Health please order your visitor pass now to secure your free pass and avoid the on-site registration fee. To register visit this link

Further details about Arab Health 2019 may be found at this link

ISO 13485: 2016 MDSAP – Gap Analysis

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, Australian and/or Canadian markets you will be required to comply with the requirements of the Medical Device Single Audit Program (MDSAP).

At Advena we have experts who specialise in guiding manufacturers to compliance whether it’s ISO13485:2016 or with the additional requirements of MDSAP and the first logical step is to perform a gap analysis.

The Advena gap analysis will evaluate your QMS and assess your level of compliance, identifying any gaps, deficiencies or nonconformities when comparing to your current QMS to the standard you wish to achieve.

After completion of the gap analysis we will provide a full written report which you can use as a guide to upgrade your QMS internally, or alternatively Advena can upgrade your QMS for an agreed fee.

This service is particularly helpful for SME’s and start-up organisations whose depth of resources may not allow a gap analysis to be conducted internally.

For more information on how Advena can assist with assessing your QMS to either ISO13485:2016 or to include the requirements of MDSAP certification or even to implement a new QMS please contact us at info@advenamedical.com for a detailed quotation.

Advena Receives ISO 13485:2016 Certification

 

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 this much sought-after certification underpins our ability to help, assist and guide manufacturers through this process, therefore if you are also looking to transition to the 2016 version of this standard or are ready to implement your own quality management system please do get in touch with us, we have a team of experts ready to help.

Email: info@advenamedical.com

A New Addition to the Advena Team

 

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 all stages of the device life-cycle such as supporting the development, initiation and running of clinical investigations, obtaining regulatory approvals and controlling PMS and vigilance activities.

His experience has involved device registrations across the globe, focusing on the EU and US where he has lead work on submissions of EU Technical Files and Design Dossiers as well as US 510(k)s, De Novos and a Pre-sub for a PMA.

Andrew also has been instrumental in instigating and maintaining numerous Quality Management Systems which he has taken through a range of successful audits including both scheduled and unannounced Notified Body audits as well as inspections from the US FDA, CFDA, ANVISA and the KFDA.

Clearly Andrew has a lot to offer our existing and prospective clients alike and we welcome him to our growing company. If you like many of our clients are looking for excellent experienced regulatory support please email Advena for a tailored solution to your regulatory needs; info@advenamedical.com

 

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