Meet the Advena Team
Advena is comprised of three business units, encompassing our broad spectrum of expertise, Pan-European operations and global client base. The team includes highly experienced practitioners with over 30 years experience in regulatory affairs.
30 years experience in global medical device regulatory affairs including the position of Vice President of International Regulatory Affairs with the US multi-national Sherwood Medical.
20 years experience in Quality Management, Medical Device Regulatory Affairs, Microbiology, Clean Room and Sterilisation Validation.
In excess of 20 years experience in Business Management, Systems & Procedures. Wide-ranging experience in the Medical Device Industry and Medical Device Regulatory Affairs, Management Representative for Quality Management Systems and EU Authorised Representative (EC REP) services.
Over 5 years’ experience in Quality Management and Medical Device Regulatory Affairs including EU submissions. Qualified Analytical Chemist with 12 years R&D Pharmaceutical experience.
A medical device regulatory consultant with a biomedical and mechanical engineering background experienced in the creation and review of technical documentation and QMS, as well as in handling vigilance issues and PMS for a vast array of medical device types and classifications.
A regulatory consultant with an MSc in Medical Statistics with Health Technology Assessment. Experienced in FDA submissions, compilation of CE technical files and global regulatory submissions, specialising in IVD devices. In-depth understanding of marketing regulations and approaches to IVD verification and validation.
A medical device consultant with extensive knowledge of the medical device regulatory field with a PhD, a MSc and a BEng in Biomedical Engineering. Also experienced in compiling and reviewing technical documentation for a variety of medical devices and IVDs in compliance with MDR/IVDR.
Quality and Regulatory Consultant with over 10 years’ experience in Medical Device Quality Management and Regulatory Affairs. Conversant with the creation, review and approval of technical documentation for both CE Technical Files and 510 (k) submissions.
Qualified Auditor with extensive knowledge of ISO 13485 and FDA 21 CFR Part 820 Quality Systems. Expertise in QMS Gap Analysis and delivering the associated education, development and improvement.
A Medical Device consultant with extensive experience of both regulatory and quality projects in accordance with both European and United States standards. Previous experience with Neurological, Orthopaedic, Contraceptive Device and Procedure Pack devices, compiling both CE Technical Files, Design Dossiers and 510 (k) submissions (k) for US market as well as submissions for Australia, New Zealand, Canada and Japan.
Over 3 years’ experience in Quality Management and Medical Device Regulatory Affairs including Technical Files, Non-EU medical device registrations and internal auditing to ISO 13485: 2016. Trained in Cosmetics regulations in accordance with EU 1223/2009 and construction of Product Information Files.
Over 6 years experienced in Business Administration, Customer Service, Account Management and sales.
Grishma joins Advena on an intern placement as part of her Master’s Degree at Aston University – MEng Biomedical Engineering, providing regulatory support to our team of consultants.