Quality and Regulatory Support
Need quality and regulatory guidance for MedTech products?
Seeking help with pre-market documentation and approval?
Want FDA and data privacy compliance for your systems?
Elevating MedTech Excellence through Quality and Compliance
At qointa, we provide expert Quality and Regulatory Support services, helping you maintain the highest quality standards, navigate complex regulatory landscapes seamlessly, and achieve compliance, whether you need pre-market documentation assistance, QMS enhancement, risk management, or cybersecurity solutions
Our Comprehensive Services
Pre-Market Submissions - 510(k), CE Marking: We assist in preparing and submitting pre-market documentation, such as 510(k) submissions and CE Marking, to gain regulatory approval for your medical devices.
QMS Implementation (QSR / ISO): Our experts guide you in implementing Quality Management Systems (QMS) that align with Quality System Regulations (QSR) and ISO standards to ensure consistent quality.
Regulatory Strategy & Compliance Plan: We develop for you a comprehensive roadmap that outlines how your software product will adhere to legal and regulatory standards in the healthcare industry, ensuring safety, effectiveness, and compliance with relevant laws and guidelines.
DHF and TD Gap Analysis: We perform thorough Design History File (DHF) and TD (Technical Documentation) gap analysis to ensure compliance with documentation requirements, facilitating smoother product development and submissions.
CAPA (Corrective and Preventive Actions): We help you identify, document, and manage Corrective and Preventive Actions to enhance product quality and prevent future issues.
Supplier Engineering: Ensure that your suppliers meet the highest quality and regulatory standards through our supplier engineering services.
Audits and Assessment: We conduct audits and assessments covering your Quality Management System (QMS), suppliers, and training to identify areas for improvement and ensure compliance.
Design Verification and Validation Services: We offer comprehensive verification and validation services, including system and subsystem testing, requirements management, reliability testing, compliance testing, and certifications.
Compliance to IEC 60601-1: Our experts perform gap analysis, compliance testing, and certifications to ensure that your medical devices meet the requirements of IEC 60601-1.
Compliance to IEC 62304 (Software Lifecycle Management for MD): We assist in adhering to the standards outlined in IEC 62304 for the software lifecycle management of medical devices.
Risk Management (Compliance to ISO 14971): We provide comprehensive risk management services, including hazard analysis, FMECA, and FTA, to comply with ISO 14971 standards.
Computer Systems and Software Validation based on FDA Regulations: We help you validate computer systems and software according to FDA regulations to ensure data integrity and security.
FDA 21 CFR Part 11 ER/ES Consulting: Our consulting services cover gap analysis, risk analysis, and remediation to comply with FDA 21 CFR Part 11 Electronic Records and Electronic Signatures requirements.
Data Privacy & Protection (US/EU): We assist in ensuring compliance with data privacy and protection regulations in both the US and the EU.
Development of SOPs and Process Guidelines: We help you develop Standard Operating Procedures (SOPs) and process guidelines that are in line with regulatory requirements and industry best practices.