FOCUS QM Strategies

FOCUS QM Strategies engages with emerging and established medical device companies providing quality assurance and regulatory affairs services to bring their medical device products to market. There is strong FOCUS establishing compliant quality management systems and auditing according to the following standards and regulations: ISO 13485:2016, MDSAP (all regions), ISO 9001:2015, US FDA 21 CFR 820, EU MDR and EU IVDR, Canadian Medical Device Regulations (SOR/98-282), Australian TGA and associated supporting standards (such as ISO 14971, IEC 62304 and CLSI guidelines). Services provided include: - Establish and maintain quality management systems - Internal audits (ISO 13485:2016, MDSAP, EU-MDR) - Establish regulatory strategy - Prepare regulatory submissions - Generate technical and design files FOCUS QM Strategies is committed to working with clients who want to bring their medical devices and IVDs to market in a COMPLIANT manner!

• Employees1
• Founded2009