Charles Edward Spearpoint, is the founder and a Director of QAEC Limited and has over twenty years experience in the medical device industry. As a Consultant Charles is flexible working at different levels within the industry and can operate across all levels to suit any organisation.
QAEC Limited is an independent Medical Device and Pharmaceutical Consultancy, based in the UK and work mainly within the areas of Quality Assurance, Quality Systems, Compliance and Regulatory affairs, Product Development and Validation Management.
QAEC Limited offer a professional service that specialises in the Medical Device and Pharmaceutical industry specifically designed to assist companies of all sizes from start up to multi-national companies.
QAEC Limited can offer technical guidance on CE marking requirements and regulatory strategies leading to the commercialisation of new products.
The implementation of Quality Management Systems meeting the requirements of 21 CFR Part 820, the Medical Devices Directive 93/42/EEC transition to EU MDR 2017/745 and EU MDR 2017/746. ISO 9001: 2015 transition to 13485: 2016 (including CMDCAS).
QAEC Limited also provide training in these areas and has worked with companies ranging from start-up companies to multi-national market leaders.
QAEC Limited can carry out internal audits, vendor audits, gap analysis, quality and regulatory compliance audits for medical device and pharmaceutical manufacturers.
QAEC Limited can assist in the preparation and review of Technical Files and Design Dossiers and assist in compliance issues related to sterilisation and microbiological control of production as applicable.