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EN ISO 13485:2016 Amendment

The much anticipated amendment to EN ISO 13485:2016 has now been published in the form of A11:2021, providing manufacturers with updated Annexes ZA and ZB to reflect the obligations and requirements of the new EU Regulations for medical devices and IVDs.

The EU Regulations clearly stipulate that all medical device manufacturers shall have a Quality Management System (QMS) in line with the Article 10 obligations within the Regulations. Devices requiring Notified Body intervention will also need to meet QMS requirements within their appropriate conformity assessment procedures, as laid out in Annex IX or Annex XI. Once the standard is cited within the Official Journal of the European Union for that Regulation, compliance with the normative references given in Annexes ZA and ZB of the standard, presumption of conformity with the corresponding Regulation and EFTA Regulations may be conferred.

EN ISO 13485:2016+A11:2021 compares the QMS requirements of Article 10 and Annexes IX and XI with the corresponding requirements of the ISO 13485:2016 standard, providing notes on whether these are covered by the standard or not. One could thus follow these notes in order to identify those areas of their QMS which will need to be updated with respect to the EU Regulations.

We would recommend that all manufacturers who are using an ISO 13485 compliant QMS to purchase this amendment and go through Annexes ZA or ZB as appropriate in order to determine which elements of the QMS will need to be revised in order to comply with the requirements of the MDR or IVDR.

Advena can conduct a comprehensive gap analysis on your existing QMS documentation in order to highlight any deficiencies with respect to the EU Regulations and ensure your system is compliant. Our Gap Analysis Reports also provide recommendations on how these gaps may be resolved as well as tips on how to improve your QMS.

New Vacancies at Advena UK

We are excited to announce, that  Advena UK are expanding!

We are looking to recruit two highly experienced regulatory professionals to join the UK team.

Our role is to support small/medium sized medical device manufacturers, & start-up organisations to achieve EU/UK/US regulatory compliance.

The positions currently are:

Medical Device Regulatory Consultant/Specialist (IVD/IVDR)

Salary: £45-£70k depending on experience

Job specification link: Advena Ltd UK V02 IVDR

Please email to discuss the opportunities available.

Kind regards,

Helen George

Business & Project Manager, UK

Published: July, 2021

 

 

 

Quality Management Systems (QMS) Under the MDR

Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. Article 10 (9) of the MDR goes into further detail.

Manufacturers should be looking closely at their QMS to ensure it meets the requirements of the Regulation. A QMS to ISO 13485:2016 will cover most of these aspects, but not all. Therefore, it will be vitally important to carry out a review of your QMS.

The implementation of the MDR to 26th May 2021 is not far away, so please use this time wisely.

If you don’t have the resources internally or locally, remember Advena have a team of consultants who can help and should you need our assistance please do contact us and we will happily discuss and provide you with a quotation to review your QMS. If you need to implement a new QMS, we can also quote for this.

Email us at: Info@advenamedical.com

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

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