Vinetta Brew MA, BSocSc (Hons), MTOPRA's Linkedin Analytics

Summary: ✦ I can help you with your regulatory compliance challenges and develop a workable, practical regulatory strategy to get your Cosmetics, Medical Devices, Drug Combination Devices, Pharmaceuticals, Personal Care & Homecare products compliant and on the market in the UK, EU and ROW. Experience: ✦ I offer over 12 years Regulatory consultancy expertise supporting global companies with regulatory compliance and CE Marking Industries: ✦ I have worked globally in MedTech, Life Sciences, FMCG, Cosmetics/Personal Care and Homecare Markets: ✦ My market experience includes, compliance for EMEA, APAC, ANZ and MENA Product Classification Expertise: ✦ Class I, II & III Medical Devices, Medicinal Products, Cosmetics, PPE Expertise: ✦ Medical Devices Regulation (EU) 2017/745 ✦ Medicinal Products Directive 2001/83/EC ✦ Cosmetics Regulation (EC) 1223/2009 ✦ UK Medical Devices Regulations 2002 ✦ Classification determination ✦ Technical file audit and remediation ✦ Declaration of Conformity ✦ Post Market Surveillance ✦ Product Recalls ✦ Clinical Evaluation Reviews ✦ Biological Safety Reviews ✦ PIFs ✦ Gap analysis ✦ CLP ✦ Product registration ✦ PIF compilation ✦ Common Technical Dossiers ✦ Facilitating Audits ✦ Training and presentations Standards Expertise: ✦ ISO 9001 Quality Management System ✦ ISO 13485 Medical Devices - Quality Management Systems ✦ ISO 14971 Application of Risk Management to Medical Devices ✦ CONTACT ME: vbrew@here2grow for a FREE Discovery call