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Quality Management System (QMS) Services for Medical Devices
30+
40+
30+
Audits
15+
Countries
100%
compliance-readiness achieved
Quality Management System (QMS) Services for Medical Devices Overview
Industry
The main purpose of QMS in the medical device industry is to ensure that the device meets the quality and safety standards established by the respective Regulatory bodies. The QMS for medical devices must comply with relevant regulations and standards such as the International Organization for Standardization (ISO) 13485:2016, United States Food and Drug Administration (US FDA) Quality System Regulation (QSR), and European Union Medical Device Regulation (EU MDR). These regulations and standards, each specific to a particular region, provide guidance and regulations for establishing, implementing, and maintaining the QMS within the respective areas. Medical device industries/organizations must establish and maintain the target country-specific standards for product distribution.
- QMS Consultancy Services to ensure seamless implementation of standards like ISO 13485:2016, US FDA 21 CFR 820, MDSAP, KGMP, BGMP, Indian MDR 2017, QSD-Taiwan, MHLW-Japan MO169 and more.
- ISO 14971 Risk Management Consulting
- QMS Remediation
- Compliance & Audit Support
- QMS Toolkit
- Document Management
- CAPA Management
- Supplier Evaluation
QMS Services throughout Product Lifecycle
Phase 1: CONCEPT
- QMS planning/strategy.
- Identification of QMS requirements based on target markets.
- Medical devices
- In Vitro Diagnostic (IVDs) devices
- Combination products
- Software as Medical Devices (SaMDs)
Pharma wizard Medical Writing Services
QMS Consultancy Services
Explore Pharma Wizard's QMS Consultancy Services for your medical device.
ISO 14971 Risk Management Consulting
Meet global Regulatory standards with Pharma wizard ISO 14971 Risk Management Services.
QMS Remediation
Tailored QMS Remediation Services to meet the stringent requirements of the healthcare industry.
Compliance & Audit Support
Leverage our expertise in Regulatory affairs and technology to establish centralized, cost-effective audit services
Document Management
Streamline QMS documentation with structured control, Regulatory alignment, and audit readiness using ISO 13485-compliant document management solutions.
Corrective and Preventive Action (CAPA) Management Services
Strengthen your quality system by identifying, resolving, and preventing quality issues through comprehensive CAPA management services
Supplier Evaluation
Ensure supplier compliance, traceability, and risk mitigation with end-to-end evaluation and qualification solutions aligned with 21 CFR 820 and ISO 13485
Quality Management System (QMS) Services for Medical Devices
- Benefits
- Advantages
- Cost-effective solutions.
- A qualified team of experts.
- An extensive partner network across the globe.
- Support with region-specific QMS services.
- Quality Assurance (QA).
- Staff Augmentation services.
- Extensive experience with diverse 510(k) registrations
- Expertise with 510(k) compilation as per US FDA Premarket Notification (510(k)) requirements
- Additional support to handle 510(k) queries.
- On-time submission of deliverables
- Up to date with US FDA new amendments on SaMD
