Medical device regulatory support and standards compliance
QFI specialities in standard and bespoke services to enable manufactures and other economic operators in the medical devices industry to fulfil, compliance obligations. Although frequently mimicked, we produce tailored solutions, documentation and specific advice for clients, consisting of detailed projects, work breakdowns to individual product conformity programmes.
Our highly-skilled and competent technical core team, supported by a network of specialist associates, can ensure fast achievement of regulatory compliance, including remediation, compliance programmes just as easily and efficiently as designing and implementing new systems.
We ensure operators, functions and processes are aligned with respective medical device operations, excel in process analysis and quality planning, integrate regulations appropriately and functionally in quality management systems and can even re-organise stagnating, stodgy and inefficient quality systems, rapidly, cost-effectively and without the malaise of copy-post and regurgitation malaise evidence with inferior competing service providers.
Our specialists are adept in most, prominent plus lesser medical device and standards models, including European directives and regulatory, superial and invoked legislation, EU member state-specific requirements; US, Canadian and Mexican regulations; Australian and other Oceanic regulations, plus many others. Our experience includes small, start-up to global, blue-chip multi-nationals-from simple ISO type systems to Corporate integrity agreement cases and so on.
QFI can produce universal systems, accommodating medical device regulations and standards, environmental (waste) management, data protection, biocides, nano-technology and software, inter alia.