IVD QARA & Clinical Affairs Consultant with experience of IVD product pathway planning including performance evaluation

QARA IVD consultant

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Responsible for Novacyt Quality, Regulatory & Clinical activities across Primer Design Ltd (Southampton) & ITIS International Ltd (Stokesley) Compliance with ISO13485, ISO9001 QMS. Compliance with 2017/746 IVDR & UK MDRWorking to ISO14971 & ISO20916Global device registrationsEuropean Person Responsible for Regulatory Compliance PRRCExec Team member

Within the Global Commercial Team and supporting the Sales & Marketing Teams, solely responsible for supporting IVD manufacturers in EMEA with Quality, Regulatory & Clinical support. Generating a pipeline of clients on Salesforce. Ten face to face visits a month across EMEA.Presenting to senior management/Exec members of IVD manufacturers- Attended medical device conferences

Managed medical device clinical studies under ISO14155, US FDAInvestigator initiated studiesSponsored studiesClinical Evaluation ReportsAI software Supported management of KOLs and clinical symposia sponsored by Optos. Supported Sales & Marketing from a clinical aspect

Management of clinical evidence of IVD medical devices in accordance with the European IVD Directive 98/79/EC. Clinical evidence encompasses scientific validity (literature searching), analytical performance (liaising with the Research and Development Team) and clinical performance (performance evaluations, marketing evaluations (liaising with the Commercial and Marketing Team). Responsible for post market surveillance for each device.Assist with the day to day management of QMS

Responsible for collating data from global performance evaluations with performance analyses on evaluations resulting in a final report.-Key person in the setting up of the quality system with an external quality consultant-Prior to CE marking, successfully managed three UK performance evaluations. Managed marketing evaluations in Eire -Working to quality standards, contributed towards the design and development of the IVD medical device and subsequent UK launch -Co-wrote a paper for inclusion in BioMed Central Microbiology titled: “Evaluation of BacLite Rapid MRSA, a rapid culture based screening test for the detection of ciprofloxacin- and methicillin resistant- S. aureus (MRSA) from screening swabs”

State registered as BMS in 1988 - Virology - testing patient samples for infectious diseases. On call for the Virology lab. Tissue culture, serology, microscopy. Supported food,dairy & water microbiology labs Singleton Hospital, Swansea1993- 1995 BMS in the Food Hygiene Lab, Colindale. Food reference testing for food poisoning outbreaks1995-1997 Senior BMS Virology Ref Lab, Colindale. Testing patient samples referred for Blood borne viruses & Retroviruses. Manufacture of virus IQCs for use in tests. PCR, Western blot, serology. MSc in Medical Microbiology 1998-2000- Senior BMS responsible for managing serology lab, tissue culture lab and electron microscopy lab on rotation. Management of day to day running of labs and staff. Ensured QMS compliant. Ensured turnaround times adhered to. Secondment for six months as PHE Accreditation Officer, Colindale 2000-2002 Accreditation Officer/Chief BMS, Colindale (Standards Unit). Responsible for generation of national SOPs for implementation into PHE labs. Sat on Advisory Committees/Working Groups. Responsible for troubleshooting National quality issues relating to PHE labs across England and Wales