Healthcare and Medical Devices
Ensuring Patient Safety and Regulatory Excellence
In the highly regulated and critically important healthcare sector, quality assurance is not just a necessity—it’s a responsibility. At Jags Assurance, we work with healthcare providers, pharmaceutical companies, and medical device manufacturers to implement robust quality and compliance systems that safeguard patient well-being and enhance product reliability. Our expertise spans global standards, including ISO 13485, ISO 9001, and regulatory frameworks such as FDA and MDR.
We understand the high stakes involved in healthcare and life sciences, where product failure or non-compliance can result in serious consequences. That’s why we focus on establishing systematic quality processes, risk management protocols, and continuous improvement initiatives tailored to the specific needs of this vital industry.
How We Add Value
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Compliance with International Healthcare Standards
We guide organizations in aligning with ISO standards, Good Manufacturing Practices (GMP), and international regulatory bodies to ensure market readiness and audit success. -
Patient-Centric Quality Solutions
Our services prioritize patient safety by improving traceability, sterilization validation, product lifecycle management, and clinical risk assessments. -
Documentation and Validation Support
We help manage complex documentation, validation protocols, and device master records, ensuring your processes are transparent, traceable, and inspection-ready.
Our Areas of Expertise
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ISO 13485, FDA 21 CFR Part 820, EU MDR compliance
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Risk management and Failure Mode and Effects Analysis (FMEA)
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Internal audits and mock inspections
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Post-market surveillance and complaint handling
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Clinical evaluation and technical documentation reviews
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CAPA systems and quality event management
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Training on regulatory updates, standards, and quality system implementation
Leveraging extensive industry expertise, Jags Assurance delivers solutions that boost efficiency, compliance, and performance.
Partner with us to build a future defined by excellence and reliability