Medical Device Validation

Description: Medical Device Registration is a mandatory regulatory process governed by the Central Drugs Standard Control Organization (CDSCO) under the Medical Device Rules, 2017. As of 2026, all medical devices and In-Vitro Diagnostics (IVDs) are categorized into four risk-based classes (Class A, B, C, or D), ranging from low-risk items like surgical dressings to high-risk implants like pacemakers. Manufacturers and importers must navigate the SUGAM portal to submit technical dossiers, including the Device Master File (DMF) and Plant Master File (PMF), while ensuring compliance with ISO 13485 standards.

Description:- Medical Device Validation Services are essential to ensure that medical devices consistently meet user needs, intended uses, and applicable regulatory requirements. Validation is a critical component in the product development lifecycle, helping manufacturers demonstrate that their devices are safe, effective, and compliant with global standards such as FDA 21 CFR Part 820, ISO 13485, EU MDR, and IEC 62304. Our Medical Device Validation Services support manufacturers at every stage from concept through production to help bring high-quality, compliant devices to market faster and with reduced risk. Our Key Services Include: Validation Planning: Development of robust, risk-based validation strategies and documentation, including Validation Master Plans (VMPs), risk assessments, and traceability matrices. Design Validation: Ensuring the final device design meets user needs and intended use under actual or simulated use conditions, in accordance with regulatory expectations. Process Validation: Verifying that manufacturing processes consistently produce devices meeting predetermined specifications, through IQ/OQ/PQ protocols. Software Validation: Validation of embedded software, software as a medical device (SaMD), and software used in production or quality systems, aligned with FDA, IEC 62304, and GAMP 5. Equipment Qualification: Installation Qualification (IQ) Verifying that equipment is installed per manufacturer specifications. Operational Qualification (OQ) Confirming the equipment operates within defined limits. Performance Qualification (PQ) Demonstrating consistent performance under routine conditions. Test Method Validation: Ensuring that analytical and mechanical test methods used to assess device quality are reliable, accurate, and reproducible. Packaging and Sterilization Validation: Verifying that packaging systems maintain sterility and integrity throughout shelf life and distribution, and that sterilization processes are effective and repeatable. Cleaning and Environmental Validation: Ensuring cleanroom environments, cleaning methods, and contamination controls meet regulatory requirements for medical device manufacturing. Usability and Human Factors Validation: Assessing the interface between users and devices to minimize use errors and enhance patient safety. Regulatory Compliance Expertise FDA QSR (21 CFR Part 820) ISO 13485:2016 EU MDR 2017/745 ISO 14971 (Risk Management) IEC 62366 (Usability Engineering) IEC 60601 (Electrical Safety)

Medical Device Validation

This service entails literature search on various database and review. The main services are: Search on various databases like PubMed, Science direct etc. Review of abstracts for inclusion in ICSR, PSURs and other specialized reports Request for articles through libraries Request for English translation if needed Review of articles for inclusion in ICSR, PSURs and other specialized reports

Understanding the risks and mechanisms of emergencies and having the skills and expertise in place to manage them is a vital part of Falck s DNA and history. This foundation enables Falck TravelCare to deliver bespoke health, safety and security risk management solutions to global companies and their global workforce as well as to travelers. Falck TravelCare bundles Falck s core competences into a global comprehensive and integrated emergency response service with 24/7/365 availability. Our global medical and security assistance services are used by numerous companies in various business sectors (insurance, finance, travel, airline, government) in their efforts to guarantee the security of their employees and customers travelling or working abroad. We prepare companies for meeting their Duty of Care and ensure compliance with their brand and social responsibility strategy. We help companies mitigate the medical and security risks faced by their global workforce and travellers through a comprehensive network of medical and security specialists worldwide. We have skilled doctors, nurses and security specialists on duty at our emergency response centres 24/7/365. Our objective is to enable workers and travellers to concentrate on their own specific business, whether they are in the United States, Ghana or Inner Mongolia. Our extensive network of providers worldwide ensures access to quality treatment and medical supervision as well as local support in emergency situations. Our services include: worldwide medical and security advice and assistance, medical and security referrals to Falck TravelCare s preferred providers, medical monitoring of patients, medical and security evacuation and repatriation, medical escorts, online medical and security information, travel safety and tracking, crisis management, remote site services, security training, risk analysis and assessments, cost management, etc.

Thanks to our scaleability, we guarantee full process relevance by using identical materials and formats adapted to a test product volume convenient for you. We will work with you to meet the regulatory expectations and define applicable test conditions for your product formulation based on your actual process conditions.

As Medical Device Inspectors become more familiar with the expectations of the Drug Inspectors for evidence of meeting labelled storage conditions, mapping and validation compliance is becoming an area of discussion during Medical Device inspections.The Medical Device Regulations require that procedures are in place to address storage and handling requirements. If your product has specific storage requirements, then you need to be prepared to provide evidence that storage requirements are being met. We can develop programs and protocols for you which help provide evidence that your handling of products complies with storage requirements.

Pharmaceutical Biological Medical Device

QA TECH is a division of GMP Technical Solutions specializing in: Validation of Operation Theatres Temperature Mapping Studies/ Filter Integrity/ Particle Counting Cascade Impactor Mensuration Services Calibration of Instruments Thermal Validation of Biomedical Equipments / Blood Bank Validation as per International Guidelines of USFDA, WHO, HTM 2025, NABH

Preparation of master validation plan for cGMP requirementPreparation of DQ, IQ, OQ and PQ documentationsPreparation of Validation and Maintenance protocolPreparation of spare parts list and maintenance scheduleHanding over of Validation documentation.

Medical Device Validation

Linguistic Validation Of Medical Questionnaires Service

Medical Device Process Validation

Temperature Mapping , Autoclave ,DHS, Tunnel validation.

Medical Device Validation

Medical Device Validation

Assisting in Validation

Validation