Established in 2015, this consultancy serves medical device manufacturers, distributors and importers, from start-ups to large corporations. Work covers quality management, regulation, clinical research and commercialisation under EU, US and global frameworks.
Services include QMS setup, quality manager and PRRC roles, MDR technical files and clinical evaluations, FDA process support and European Authorised Representative services. It also offers CRO project management, GLP studies, trial audits, IEC 60601 and ISO 10993 testing and training. Regulatory strategy, reimbursement, market analysis and due diligence are available. The office is in Stella Business Park, with an accessible entrance and parking.
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