ME3 Consultancy Ltd
Medical Devices - Sheffield, England, United Kingdom
ME3 Consultancy Ltd Employees
ME3 Consultancy Ltd Details
Bringing medical device concepts to commercial launch & establishing routine manufacture. Offering the following services: 1) Design, Research & Development- Translating product ideas/market concepts into manufacturable devices- Evaluating existing product ranges; providing sustainable manufacturable solutions passing cost savings onto clients- Internal CAD visualisation and Prototyping capabilities 2) Quality & Regulatory Assurance - Installation and operation of full Quality Management Systems compliant to EN ISO 9001:2015, EN ISO 13485:2016 and FDA 21 CFR Part 820 inclusive of;▪︎ Quality Manuals ▪︎ Standard Operating Procedures (SOP)▪︎ Forms and Working Instruction - Internal and external auditing to above standards and regulation - Technical file compilations, inclusive of; device master record, device history records and design history file compilations - Undertake BSI audits and inspections - Verification and Validation activities on packaging and component manufacture, cleaning and sterilisation, transit and packaging expiration processes to ensure they meet clients customer and regulatory requirements3) Project Management - Taking conceptional design, through;▪︎ verification and validation activities leading to ▪︎ commercial product launch - Routine manufacture by means of proven pathways and links to medical device manufacturers.
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