Vision 28
Vision28 is an association of expert consultants with decades of experience in establishing quality systems and attaining market clearance for medical device companies active in Canadian, the US, and European regulatory markets. Their team has experience developing and defending quality systems for companies ranging from Fortune 100 to start-ups, offering services including QMSL, cloud-based document control, and regulatory support. They focus on helping clients navigate FDA, EU MDR, ISO 13485, MDSAP, and other regulatory standards, with a mission to provide pragmatic, efficient, and timely regulatory and quality assurance consulting.
Industries
Nr. of Employees
small (1-50)
Vision 28
Products
Digital/PDF-based LEAN QMS package (SOP bundle)
A deployment-ready QMS package comprising a set of SOPs, work instructions and templates suitable for rapid implementation (PDF/Word + electronic signature workflows).
Digital/PDF-based LEAN QMS package (SOP bundle)
A deployment-ready QMS package comprising a set of SOPs, work instructions and templates suitable for rapid implementation (PDF/Word + electronic signature workflows).
Services
On-site or remote internal, mock and third‑party audits compliant with ISO 19011 and certification requirements for medical device standards.
End-to-end 510(k) services including pre-market evaluation, document preparation, submission and liaison with the FDA, plus post-market support.
Design, customization and deployment of LEAN QMS solutions (digital/PDF-based or cloud-based) including SOP bundles and staff training.
Drafting and submission of responses to FDA Form 483 and Warning Letters, plus follow-up mock inspections and verification of remediation.
Support to plan, document, execute and close medical device recalls, including regulator notifications, monthly status updates and effectiveness checks.
Ongoing outsourced quality and regulatory support acting as a virtual quality/regulatory department to provide QMS administration, training and advisory services.
On-site or remote internal, mock and third‑party audits compliant with ISO 19011 and certification requirements for medical device standards.
End-to-end 510(k) services including pre-market evaluation, document preparation, submission and liaison with the FDA, plus post-market support.
Design, customization and deployment of LEAN QMS solutions (digital/PDF-based or cloud-based) including SOP bundles and staff training.
Drafting and submission of responses to FDA Form 483 and Warning Letters, plus follow-up mock inspections and verification of remediation.
Support to plan, document, execute and close medical device recalls, including regulator notifications, monthly status updates and effectiveness checks.
Ongoing outsourced quality and regulatory support acting as a virtual quality/regulatory department to provide QMS administration, training and advisory services.
Expertise Areas
- Regulatory compliance and submissions (FDA, EU MDR, CMDR, MDSAP)
- Quality management system (QMS) design and implementation
- Quality audits and inspection readiness
- 510(k) clearance and premarket strategy
Key Technologies
- Cloud-based document management
- Electronic signature-enabled QMS workflows
- LEAN quality system methodologies
- ISO 14971 risk management processes
News & Updates
Recent Projects
Partnering with our team of experts allows you to focus on your business while we handle the rest. Review some of our most recent projects including 510(k) clearances, regulatory strategies, and quality system implementations.
Industry Blog and Updates
Regular updates on industry changes, guidance, and best practices for medical device regulation and quality management.
All Posts
A collection of blog posts covering topics like digital QMS, importing medical devices, risk analysis, and FDA compliance.
Vision28 Blog and Updates
Latest articles and updates from Vision28's industry blog.
20+ Years Experience
Over two decades of experience in regulatory and quality assurance consulting.
100+ Clients Served
A broad client base including startups and Fortune 100 companies across the globe.
Recent Projects
Partnering with our team of experts allows you to focus on your business while we handle the rest. Review some of our most recent projects including 510(k) clearances, regulatory strategies, and quality system implementations.
Industry Blog and Updates
Regular updates on industry changes, guidance, and best practices for medical device regulation and quality management.
All Posts
A collection of blog posts covering topics like digital QMS, importing medical devices, risk analysis, and FDA compliance.
Vision28 Blog and Updates
Latest articles and updates from Vision28's industry blog.
20+ Years Experience
Over two decades of experience in regulatory and quality assurance consulting.
100+ Clients Served
A broad client base including startups and Fortune 100 companies across the globe.