Need help to comply with emerging regulations and standards ?
Our Regulatory Compliance services can help you minimize the non-compliance risk
For Medical Device Industry
A through Gap Analysis by our auditing team will access your business readiness to meet and comply with applicable industry’s standards and best practices. Our auditing team is specialized in performing MDSAP mock audit and providing an effective remediation plan to address any gaps.
Our audit team can help you monitor your supply chains through inspecting and auditing materials/services/process of your suppliers at regular intervals and provide you with a detail audit report
Our qualified audit professionals can perform a Mock or External audit of your process and controls and help you get prepare for regulatory audits. Our detail audit report provides an objective insight and remediation into deficiencies of regulatory compliance, best practices and industry standards.
We can author and review your Medical Device Design Control Procedures, Design History Files and Document Templates in accordance with the FDA, MDSAP, MDR, ISO 13485, ISO 14971, IEC 62304 and other applicable best practices and standards.
We provide full range of Validation services. We can assist you in evaluating, optimizing and ensuring the compliance of your Computer Systems including hosted cloud solution, Process, Equipment, Facility and utilities. whether you have a complex validation project or need a validation resource for short term, we can provide the level of validation expertise to meet your needs. Learn More..
IEC 62304 is critical for Medical Device Software. Our experts can help you comply with this standard by identifying the gaps in your software development, Maintenance, Risk Management, Configuration Management, Testing, Problem Resolution, and traceability processes.
Our Risk Management experts can assist you in establishing a robust ISO 14971 based Risk Management process and document FMEA, Risk Mitigation and other risk templates that can help identifies hazards, estimates and evaluates the severity of risks, controls risks and monitors the effectiveness of those controls throughout the product’s lifecycle.
Our Quality expert can help you establish CAPA procedure, CAPA templates and provide training to staff on conducting CAPA and performing root cause analysis with techniques including Fish Bone, 5 Whys, FMEA and others.
For your hosted solution ( private cloud/ Iaas/Pass/Saas) our Data center / Cloud compliance services can help ensure hardware and infrastructure are qualified, your data center is in equipped with required physical and digital security, your hosted solution is HIPPA compliant and in compliance with Data security and privacy directives and regulations.