SQR Consulting Information

Brazilian-based regulatory affairs consulting company focused on risk-based medical device lifecycle compliance. Aspects include regulatory systems (ANVISA, EU, FDA), quality systems (ISO 13485, ISO 9001, RDC 16 – ANVISA, FDA QSR), risk management (ISO 14971), product safety (IEC and ISO standards), product lifecycle testing and management, quality and regulatory auditing. SQR Consulting is introducing a new, high-quality, life-cycle integrated solutions vision to the medical device regulatory consulting business in Brazil. We focus not only in compliance, but on a regulatory strategy that uses regulatory compliance to fulfill the business needs in a structured way. As risk management in the product life-cycle is the base for regulatory requirements, we focus on a risk management, life-cycle based regulatory strategy.