Strategiqual is a consulting company located in the center of Paris and operating in Europe, with extensive experience in Europe and the US. Its area of expertise covers pharmaceutical products, medical devices and biotechnology. Strategiqual has in-house expertise in the areas of regulatory affairs, strategic plans, gap analysis, risk analysis, audits, product compliance, quality management systems implementation. Specialties : - Systems approach for designing Quality Management Systems (pharmaceutical products, medical devices, biotechnology) - Drug device combinations (the so called "rule 13" of directive 93/42/CEE) - Innovative medical devices: quality and regulatory approaches;