Our specialists provide the expertise and assistance you need. When a regulatory agency conducts an audit, you can count on smart QARA  to step in with the answers. In fact, our specialized team members will accompany you during your  internal and external audits conducted by regulatory and third-party auditors .

Additionally, our team will assist with supplier audits to ensure your vendors are providing quality products and services per your specifications. In addition, risk management can be the most critical part of medical device development. We provide rigorous risk management procedures and training tools to ensure product safety and efficacy. From initial assessment to post- market changes,

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Our experts at smart qara will write standard operating procedures, work instructions, and quality forms. We will also train you and your team members for compliance with the FDA Quality System Regulations (QSR) 21 CFR 820 and ISO 13485, MDSAP.

Additionally, if you find yourself short on resources for product launch, we can serve as your quality department. We offer quality management services as you ramp up production and enter the medical device market.