Virtual Quality System Implementation in 7 Steps
Below are the seven steps required to implement a successful Virtual QMS that ensures compliance with FDA 21 CFR 820 and ISO 13485 standards.
Implementation Process
Virtual Quality System Implementation Made Simple
For small and startup medical device companies seeking regulatory compliance.
Qualified Users
Users that connect to your files and are qualified per 21 CFR 820 and ISO 13485, ensuring proper training and competency for quality system management.
Technology Infrastructure
Laptops & internet connectivity so users can seamlessly connect to your files and maintain continuous access to quality documentation.
Electronic Signatures
Documents approved using electronic signature that is compliant to FDA 21 CFR Part 11, ensuring legal validity and traceability.
Cloud-Based Storage
Quality records stored on a cloud-based service that is compliant to FDA 21 CFR Part 11, providing secure and accessible documentation.
Records Organization
Records organized in a logical order that supports change control and records management/retention, ensuring efficient retrieval and compliance.
Compliant Documentation
Quality procedures, forms and logs that are compliant to 21 CFR 820 and ISO 13485, providing the foundation for your quality system.
Document Structure
Efficient document filing structure that streamlines access, reduces search time, and maintains organizational consistency across all quality documents.
Our VQMS Services
Comprehensive Quality System Support
We specialize in helping small startup medical device companies with their Quality System implementation needs.
Virtual QMS Implementation
We help medical device companies implement a VQMS (Virtual Quality Management System), significantly reducing the cost of maintaining physical office space while ensuring full regulatory compliance.
- FDA 21 CFR 820 compliance
- ISO 13485 alignment
- Cloud-based document management
- Electronic signature integration
- Virtual-first approach
- Cost-effective implementation
Document Control Management
Complete management of data organization, document changes, and maintaining master indices for document control information.
- Data organization systems
- Document change processing
- Master index maintenance
- Version control management
- Records retention policies
- Audit trail documentation
Training & Employee Qualification
We help medical device companies establish employee qualifications, identify training needs, and establish comprehensive employee training programs tailored to your specific requirements.
- Employee qualification programs
- Training needs identification
- Comprehensive training programs
- Competency assessments
- Training record management
- Ongoing development plans
Supplier Management
We help medical device companies establish robust supplier control programs and develop comprehensive processes to qualify and manage suppliers throughout the product lifecycle.
- Supplier control programs
- Qualification processes
- Supplier auditing
- Performance monitoring
- Risk-based supplier management
- Approved supplier lists
CAPA Implementation
We help medical device companies establish comprehensive CAPA programs, provide CAPA process training, deliver root cause analysis training, and implement and manage ongoing CAPA programs.
- CAPA program establishment
- Process training
- Root cause analysis training
- Ongoing program management
- Effectiveness verification
- Trend analysis
Quality System Remediation
We help medical device companies perform comprehensive Quality System gap assessments and provide strategic recommendations for potential improvement opportunities.
- Gap assessments
- Strategic recommendations
- Improvement planning
- Compliance gap closure
- Process optimization
- Audit preparation
Common Questions
Virtual QMS Implementation FAQ
Quick answers to the questions medical device founders ask most about implementing a Virtual QMS. See the full FAQ for more.
How long does a BushmanQC Virtual QMS implementation take?
Most implementations take 8–16 weeks from kickoff to a fully usable, audit-ready system. The seven-step process delivers usable pieces of the QMS at each phase rather than waiting until the end.
Does a Virtual QMS satisfy FDA 21 CFR 820 and ISO 13485?
Yes. Every BushmanQC Virtual QMS is designed from day one to satisfy FDA 21 CFR 820, ISO 13485, and 21 CFR Part 11 — and is aligned with the FDA's Quality Management System Regulation (QMSR), in effect since February 2, 2026.
Do I need separate CAPA, supplier management, and document control programs?
Each subsystem — CAPA (21 CFR 820.100), supplier management (21 CFR 820.50), and document control (21 CFR 820.40) — has distinct regulatory requirements but is implemented as part of one cohesive Virtual QMS, not as standalone systems. BushmanQC builds them so they reinforce each other.
Can BushmanQC remediate an existing Quality Management System?
Yes. Quality System Remediation includes gap assessments against the QMSR (21 CFR 820), ISO 13485, and 21 CFR Part 11, plus a prioritized remediation roadmap. We support both incremental remediation and full-system rebuilds for companies preparing for an FDA inspection or major audit.
Ready to Implement Your VQMS?
Let's discuss how these 7 steps can transform your quality management system and ensure regulatory compliance.
- Free 30-minute consultation
- Customized implementation plan
- FDA & ISO compliance expertise
Schedule Implementation Consultation
Find out how our 7-step process can transform your quality management and ensure regulatory compliance.
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