BushmanQC Virtual QMS
Virtual Quality Management
Made Simple
Each medical device company needs a Quality Management System. But which is best for you? Ask Nellie, and find out in 30 minutes, free!
- FDA 21 CFR 820
- ISO 13485
- 21 CFR Part 11
- Virtual-First
Virtual QMS Explained
What Is a Virtual Quality Management System?
A plain-English answer to the question every medical device founder asks first.
A Virtual Quality Management System (VQMS) is a fully cloud-based Quality Management System for medical device companies — purpose-built to satisfy FDA 21 CFR 820, ISO 13485, and 21 CFR Part 11 without the overhead of a traditional, on-premises QMS. Every quality record — procedures, training files, supplier qualifications, design history files, CAPA records — lives in compliant cloud storage, signed with 21 CFR Part 11-compliant electronic signatures, and accessible from anywhere your team works.
For a small or startup medical device company, a Virtual QMS removes the biggest barriers to compliance: the expense of physical office space, paper-based document control, and the headcount needed to maintain an in-house quality function. Instead, you get a compliant-from-day-one system that scales with your product, supports remote teams, and is ready for an FDA inspection or ISO 13485 audit on day one.
BushmanQC implements your Virtual QMS in seven defined steps — from qualifying users through compliant documentation — so you can stop guessing about quality and get back to what you do best: bringing safe, effective medical devices to market.
Our VQMS Services
We Specialize in Helping Small Startup
Medical Device Companies
We help with Quality System implementation needs, providing expert guidance and virtual solutions that reduce costs while maintaining full compliance.
Virtual QMS Implementation
We help medical device companies implement a VQMS, significantly reducing the cost of maintaining physical office space while ensuring full regulatory compliance.
Document Control Management
Complete management of data organization, document changes, and maintaining master indices for document control information.
Training & Employee Qualification
We help establish employee qualifications, identify training needs, and build comprehensive employee training programs tailored to your requirements.
Supplier Management
We help establish robust supplier control programs and develop comprehensive processes to qualify and manage suppliers throughout the product lifecycle.
CAPA Implementation
We help establish comprehensive CAPA programs, provide process training, deliver root cause analysis training, and manage ongoing CAPA programs.
Quality System Remediation
We help perform comprehensive Quality System gap assessments and provide strategic recommendations for potential improvement opportunities.
Regulatory Foundation
FDA 21 CFR 820 & ISO 13485 Compliance, Without the Overhead
Your Virtual QMS is built from day one to satisfy the standards that matter for US and international medical device markets.
FDA 21 CFR 820 (QSR / QMSR)
The US FDA's Quality System Regulation for medical device manufacturers — and its 2026 successor, the harmonized Quality Management System Regulation (QMSR). We design every Virtual QMS to meet both, so you're audit-ready before, during, and after the transition.
ISO 13485
The international standard for medical device quality management. Aligning with ISO 13485 from day one keeps the door open for European, Canadian, and global markets — without bolting on a second quality system later.
21 CFR Part 11
Compliant electronic records and electronic signatures. Every document, training record, and CAPA in your Virtual QMS is signed and stored in a way the FDA recognizes — no paper, no scanned signatures, no audit findings.
About BushmanQC
Your Virtual Quality Management System Partner
We help small startup medical device companies implement comprehensive quality systems while reducing operational costs through virtual solutions.
A simple, easy-to-use Virtual Quality Management System (VQMS) designed specifically for companies seeking regulatory compliance with FDA 21 CFR 820 and ISO 13485 standards.
Meet Nellie Bushman, Quality Expert & Founder
Ready to Simplify Your Quality Management?
Let's discuss how our Virtual QMS can help your medical device company achieve compliance while reducing costs.
- Free 30-minute consultation
- FDA & ISO compliance expertise
- Virtual-first approach saves costs
Partner With Us
Ready to simplify your quality management system and focus on innovation? Let's discuss how we can support your mission.
Schedule a Consultation