Quality Services
Quality Assurance
At ND Global, we are dedicated to establishing, implementing, and continually enhancing robust and compliant Quality Management Systems (QMS). Our commitment to excellence drives organizational value and, most importantly, ensures patient well-being and the delivery of top-tier products.
We offer tailored services to support medical device manufacturers across domains, including adherence to the U.S. FDA Quality System Regulation (QSR), EU Medical Device Regulation (MDR), and ISO standards. With a dynamic team of experts experienced in collaborations with both Fortune 100 enterprises and nimble startups, we excel in tailoring QMS to manufacturers’ unique needs.
ND Global Team is primed to offer streamlined, cost-effective solutions, including:
Evaluation of conformity to FDA 21 CFR Part 820 QSR, ISO 13485, ISO 9001, MDR 2017/745, and the Medical Device Single Audit Program (MDSAP). Expert assistance in rectifying identified gaps.
Comprehensive approach to root cause analysis and CAPA implementation.
In-depth review of existing procedures and records, as well as creation and execution of design control processes, procedures, and documentation. And, Development or evaluation of Design History Files (DHF).
Crafting comprehensive DMRs or evaluating existing ones for adherence to regulatory standards.
Comprehensive assessment and analysis to ensure product safety.
Rigorous internal assessments to identify areas for enhancement and compliance optimization.
Mock inspections in anticipation of regulatory evaluations in various jurisdictions, including the U.S., EU, China, and Japan.
Thorough process validation to ensure consistency and conformity.
Customized quality system creation and implementation in alignment with FDA 21 CFR 820, ISO 13485, ISO 9001, and MDR requirements.
Swift resolution of quality system deficiencies and non-compliance issues.
Review, assess, and develop risk management plans, analyses, and reports.
Assessment of compliance with relevant industry standards.
Comprehensive audits of suppliers to ensure adherence to quality and regulatory standards.
To ensure the quality and reliability of an organization based on its intended use.
ISO 13485
The industry standard for Quality Management Systems (QMS) for the medical device sector is ISO 13485, which the medical sector uses to guarantee that all medical devices adhere to customer requirements and legal requirements for regulatory compliance. To keep staff members and patients safe in clinics, hospitals, and other medical settings, the ISO 13485 certification has become a valuable credential for the medical device industry.
ND Global provides comprehensive assistance throughout the entire process of acquiring the ISO 13485 certificate.
MDSAP
The Medical Device Single Audit Programme enables an Auditing Organisation recognized by MDSAP to perform a single regulatory audit of a manufacturer of medical devices that complies with the pertinent specifications of the regulatory authorities taking part in the program.
The MDSAP has several international partners, including
- Therapeutic Goods Administration of Australia
- Brazil’s Agência Nacional de Vigilância Sanitária
- Health Canada of Canada
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- US Food and Drug Administration of U.S
ND Global supports the complete process of obtaining the MDSAP — ND Global is well-positioned to support its clients at various stages of getting the MDSAP audit certificate.
Verification and Validation
ND Global excels in Verification and Validation for medical devices. Our process verifies compliance with specific requirements and effectively confirms intended use to meet user needs. Our expertise helps in regulatory compliance and outstanding device performance.
V&V Services
Verification, Software Verification, Performance Testing, Risk Assessment, Documentation Review, Design Validation, Software Validation, Clinical Validation, User Testing, and Process Validation.
