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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!

Meet Advena at MEDICA 2014 – Düsseldorf

For those of you visiting MEDICA in Dusseldorf on November 12th to 15th you will find John Adcock and Farhaan Shaikh available to meet face to face on both Thursday and Friday. This is a big opportunity to network so let us know early if you will be there so we can arrange to get together.

Particularly on the Thursday we will be at the UK Pavilion in Hall 16 using the facilities of the Association of British Healthcare Industries (ABHI) with meeting tables, meeting rooms and refreshments. If you would like to discuss with us any regulatory and or quality issues please email now to book our time early.

On the Friday we will also be available to meet any clients who have their own booths, again let us know well in advance, the area is huge and we will have to plan our visits accordingly.

The show runs from 10.00 until 18.30 each day.

We look forward to meeting all our clients who will be in Germany at that time, as well as a lot of new faces!

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