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.
Over 15 years’ experience within Medical Device Regulatory, with 10 years of those in Consultancy. Specialising in single use, sterile devices due to a strong microbiology background (<20 years). Involved in numerous successful CE marking projects ranging from class III to self-registration class I devices for European submissions along with US and Canadian registration and submission. Implemented, managed and audited numerous ISO 9001, ISO 13485, US 21 CFR 820, JPAL Quality Management Systems. Qualified Internal Auditor and Responsible Person Specialist for Cosmetic products.
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.
A senior Consultant with over 9 years in medical devices industry working on airways, COPD, IVF and ventilator devices. Responsible for providing regulatory consultancy to clients seeking to obtain or maintain CE marking for a broad range of medical devices (MDD Classes I, IIa, IIb and III). Review and collate Technical files including Clinical Evaluation Report to MEDDEV 2.7.1 rev 4, Risk Management to ISO14971 and post market surveillance plans/reports. Assist clients with ISO13485 related activities including Quality Systems gap analyses, procedures and internal audits. 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.
Born and raised in Australia and now enjoying a new lifestyle in Malta. Has over 20 years of experience in Business Administration and Customer Service.
After completing her Internship at Advena, Grishma obtained an MEng in Biomedical Engineering. She continues to support the Consultancy team gaining particular experience in the creation, development and completion of Clinical Evaluation Reports to MEDDEV 2.7.1 rev 4 and Biological Evaluation Assessments to the requirements of EN ISO 10993.
Helen joins Advena as our Business and Project Manager. She has over 6 years in the medical device industry experience in managing developmental projects, and has held key roles supporting Technical, Quality & Regulatory Departments. Most recently, she has set-up and managed a multi-site ‘proof of concept’ clinical trial to collect sufficient data to apply for and be awarded a claim extension for the test device. Previous work experience spans more than 20 years’ in Operations Management and Training. Helen also has an MSc in Occupational Psychology and is Prince2 Practitioner qualified.
Jessica joins Advena as Business Administrator (Jnr) after recently graduating with a BA(Hons) in Business and Finance. Her specific role is to support the administration team within the UK operation.