Leeanne Baker's Linkedin Analytics

Medical Device consultant with extensive experience of both regulatory and quality projects in accordance with both European and United States standards. My previous roles within Neurological, Orthopedic, Contraceptive Device and Procedure Pack companies have made me routinely work on product Technical Files and Design Dossiers including Essential Requirements, Risk Management and Clinical Literature Evaluations for CE marking and 510(k) projects as well as submissions for worldwide markets including Australia, New Zealand, Canada and Japan. EXPERIENCE • MDR transition • MDSAP • Compilation of regulatory submission including Design Dossiers / Technical Files • CE-Marking Class I, and II a and III MDD and Class III AIMD medical devices • Biological Evaluation reviews & Clinical Evaluations including clinical literature reviews in line with the requirements of the revised MDD Annex X • Risk analysis & risk management activities • Implementation of various standards, Directives and Regulations including ISO 13485, EU Directive 93/42/EEC, MDR • Implementation of ISO 13485, FDA 21 CFR Part 820, Canadian ISO 13485 and Japanese GMP requirements into quality management systems • On-site regulatory support to ongoing design projects bringing various medical devices to market including Class II b and III • Control of Internal Quality System Audits • Internal Auditor and Supplier Auditor • Representative during third party audits including BSI, LRQA and TUV • Maintenance and reporting of Non-Conformity Reports and Observation Actions Plans • Review of labeling materials and evaluation of marketing collaterals • Designing, writing and conducting training courses • Complaint handling Specialties: ISO 13485:2016, MDR Transition, Clinical Evaluations, Regulatory Strategy, Auditing, World wide Medical Device Regulations and Quality Assurance Contact me at [email protected]