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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

Advena Add More Experience to Their Team

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 a Lead Assessor for EN ISO 13485 and ISO 9001 systems covering all medical devices including IVD devices. Richard is a certified Auditor for almost all aspects of device CE marking, CMDCAS and overseas GMP requirements and has been closely involved in managing Notified Body audit teams. Richard is also an MDSAP lead auditor.

Specifically, Richard has been involved in management teams responsible for Quality Management Systems and Technical Files which included IVD Devices, Pregnancy Test Kits, Contact Lens Solutions, Eye Drops and Ear Drops plus the management and execution of associated supplier and internal audits.

This experience has involved working with risk management and the preparation of technical documentation including the classification conversion of cosmetic products to medical devices – an important issue under the new MDR and IVDR regulations.

Richard’s qualifications include an MSc in Structural Molecular Biology with a dissertation on the Structure and Function of Antibodies (specific to IVD research) and he is now completing a dissertation on Medical Device Regulation. These higher level qualifications complement an earlier BSc in Biomedical Science where study topics included biochemistry, medical microbiology, biotechnology, genetics, and immunology.

Richard’s background is specifically of note when considering the new classification systems for IVD devices in the EU.

Undoubtedly Richard has a wealth of experience to offer our existing and prospective clients alike and we welcome him to our expanding company. If like many of our clients you are looking for excellent experienced regulatory support please email Advena for a solution to meet your regulatory needs, please 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

 

Another Advena Success!

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 you are looking to introduce a quality management system or to transition to ISO13485:2016 and need advice and consultancy please do contact us we have a team of experts ready to help!

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