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.
Company Details
- Employees
- 5
- Founded
- -
- Address
- Av Ceci, São Paulo,04065-004,brazil
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- sqrconsulting.com.br
- Keywords
- MDD, ANVISA, FDA, quality systems, ISO 13485, ISO 9001, GMP, QSR, 21CFR Part 820, RDC 16, risk management, ISO 14971, usability, IEC 62366, medical device software, IEC 62304, medical electrical equipment, IEC 60601.
- HQ
- São Paulo
- Competitors
- P&F Products & Features GmbH, Kamelion Clinical Research Consulting, HSC GLOBAL, Regulatory Affairs Professionals Society (RAPS), ABNT - Associação Brasileira de Normas Técnicas, AKRO Regulatory Affairs, VESTA ACADEMY - BUILDING MINDS, European Commission, Setormed, ISO - International Organization for Standardization.
Sqr Consulting Questions
Sqr Consulting's website is sqrconsulting.com.br
Sqr Consulting's LinkedIn profile is https://br.linkedin.com/company/sqr-consulting
Sqr Consulting has
5 employees.
View email and phone details for 5
employees at Sqr Consulting.
Sqr Consulting's industry is
Medical Equipment Manufacturing
Sqr Consulting's top competitors are
P&f Products & Features Gmbh,
Kamelion Clinical Research Consulting,
Hsc Global,
Regulatory Affairs Professionals Society (Raps),
Abnt - Associação Brasileira De Normas Técnicas,
Akro Regulatory Affairs,
Vesta Academy - Building Minds,
European Commission,
Setormed,
Iso - International Organization For Standardization.
Sqr Consulting's categories are Medical Equipment Manufacturing
Sqr Consulting's founding year is 2007
