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@advena.mt
