Medical Devices Industry
Ensuring Device Safety, Quality & Compliance Through Proven Software Validation
The medical devices industry plays a critical role in diagnosing, monitoring, and treating patients. From life-supporting equipment to diagnostic tools, device performance can directly impact patient safety. Manufacturers must adhere to strict international standards to ensure products are safe, reliable, and effective throughout their lifecycle. At GMP Navigator, we help medical device companies validate their computerized systems—covering design, manufacturing, quality control, and traceability—so that every device meets the highest safety, quality, and compliance standards.
Products We Support
Infusion Pumps
Devices that deliver controlled amounts of fluids, such as medications or nutrients, into a patient’s body.
Require complete traceability of components, supplier quality control, and documentation of the manufacturing process.
Blood Glucose Monitoring Systems
Portable or implantable devices that measure glucose levels for effective diabetes management.
Management of device history records (DHRs), supplier material compliance, and controlled change management for manufacturing processes. This safeguards data integrity from design through post-market service records.
Craniovertebral & Cervical Implants
Specialized implants used in spinal and cranial surgeries.
Systems must ensure traceable design specifications, approved vendor lists, and quality inspection records for implants. Systems are validated to control revisions, manage risk assessments, and store compliant product history documentation.
Implantable Cardioverter Defibrillators (ICDs)
Life-saving devices that detect and correct abnormal heart rhythms.
Validation covers stringent component tracking, manufacturing process controls, and device history accuracy. This enables seamless audit readiness and supports compliance with FDA 21 CFR Parts 820, 870, and ISO 13485.
Ventilators
Critical life-support systems that assist or replace spontaneous breathing.
Require accurate recording of production steps, preventive maintenance schedules, supplier quality monitoring, and non-conformance handling. All records should be maintained in secure, compliant formats for regulatory review.
Applicable Regulatory Guidelines
Our validation processes align with the most important global standards for medical devices:
- FDA 21 CFR Part 820
Quality System Regulation (QSR) – Sets requirements for design controls, production, and process validation.
- FDA 21 CFR Part 870, 888, and 882
Covers specific device categories:
- Part 870: Cardiovascular Devices
- Part 888: Orthopedic Devices
- Part 882: Neurological Devices
- ISO 13485
Quality Management System for Medical Devices – International standard for quality system requirements in device manufacturing.
- ISO 14971
Risk Management for Medical Devices – Framework for identifying, evaluating, and controlling device-related risks.
- FDA 21 CFR Part 11
Electronic Records and Electronic Signatures – Governs the secure and compliant use of electronic data in regulated environments.
- GAMP 5
Good Automated Manufacturing Practice – Risk-based approach for validating computerized systems.
Why Software Validation Matters in Medical Devices
In the medical devices sector, the accuracy and compliance of ERP and QMS systems are as critical as the devices themselves. These systems manage core processes such as supplier qualification, material traceability, production batch records, calibration schedules, and post-market surveillance data. If ERP or QMS software fails, it can lead to incomplete documentation, missed quality checks, or non-compliant manufacturing records—jeopardizing product release and regulatory approval. Validating these systems ensures data integrity, process control, and continuous compliance with global medical device regulations.
Benefits of ERP and QMS Software Validation for Medical Devices
- Product Quality & Reliability
- Maintain complete and accurate device history records (DHRs)
- Ensure controlled workflows for production, inspection, and release
- Prevent errors in batch traceability and quality checkpoints
- Regulatory Compliance
- Align with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and global QMS requirements
- Demonstrate validated control of all quality and manufacturing processes
- Maintain readiness for FDA, ISO, and notified body audits
- Traceability & Documentation Control
- Track components from supplier to final device with validated data integrity
- Manage engineering change orders (ECOs) and revisions with compliant workflows
- Maintain secure, version-controlled quality records
- Risk & Quality Management
- Integrate validated risk assessments and mitigation tracking into QMS workflows
- Control non-conformance and CAPA processes to prevent recurring issues
- Provide real-time quality metrics for decision-making
- Audit & Submission Readiness
- Produce accurate, regulator-ready records directly from validated ERP/QMS systems
- Reduce manual documentation errors and audit preparation time
- Support faster approvals with complete, compliant data trails
Partner with GMP Navigator
Whether you are implementing a new ERP or QMS platform, upgrading to meet the latest regulatory requirements, or preparing for an FDA or ISO audit, GMP Navigator ensures your systems are fully validated and compliant. At GMP Navigator, we help medical device companies validate their computerized systems—covering design, manufacturing, quality control, and traceability—so that every device meets the highest safety, quality, and compliance standards.
We specialize in end-to-end validation of ERP and QMS solutions that support critical medical device operations—covering supplier management, production control, quality inspections, CAPA processes, calibration schedules, and post-market surveillance tracking. Our validation approach ensures your systems not only meet FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements but also operate with complete data integrity and process reliability.
Why Choose GMP Navigator?
Trust GMP Navigator, because validation should always be right.
- End-to-End Validation - Comprehensive support from User Requirements (URS) to Final Validation Reports.
- Multi-System Expertise - Proven experience with ERP, QMS, WMS, MES, and other critical systems.
- Global Regulatory Compliance - Alignment with FDA, GAMP 5, 21 CFR Part 11, Part 210/211, Part 820, FSMA, and more.
- GAMP 5-Compliant Documentation - Risk-based, audit-ready documentation that meets industry standards.
- Flexible Engagement Models - Choose from Validation Toolkit, Complete Software Validation, Validation-as-a-Service (VaaS), Gap Assessments, and Training.
- Experienced Cross-Functional Team - Deep domain knowledge in regulations, ERP systems, and industry processes.
- Reliable, On-Time Delivery - Projects completed on schedule and within budget, every time.
Services We Offer
Our flexible engagement models are designed for businesses of all sizes.
Complete ERP Software Validation
Complete end-to-end ERP Software Validation
Validation Toolkit
Ready-to-use templates aligned with norms like FDA & GAMP 5
Complete QMS Validation Services
Complete end-to-end QMS validation service
Validation-as-a-Service (VaaS)
Ongoing validation & monitoring for contract-period
Gap Assessments & Training
Identify gaps, train your team, and always stay compliant