Vision28

Vision28 is a regulatory affairs and quality assurance consultancy founded in 2014 that specializes in helping medical device companies navigate FDA, Canadian, and European regulatory requirements. The firm reports serving over 100 clients ranging from Fortune 100 corporations to early-stage startups seeking their first product approvals.

The company's core service offerings include FDA 510(k) clearance submissions, quality management system implementation, FDA 483 response consulting, product recall management, and quality audits. Vision28 has developed QMSL, a lean quality management system designed for startups and growing companies, along with cloud-based document control solutions for multinational operations. Their team brings experience across device classifications and regulatory pathways in multiple international markets.

The consultancy maintains a small team of three named consultants with backgrounds spanning Fortune 100 companies and medical device startups, positioning them to serve organizations at various stages of growth and regulatory maturity.

Organizations should consider Vision28 when they need pragmatic regulatory guidance from consultants who have worked across company sizes and regulatory jurisdictions. The firm's lean quality system approach may particularly appeal to resource-constrained startups avoiding over-engineered compliance frameworks.

Expect engagement with senior-level consultants who have held quality and regulatory executive roles. Their experience defending quality systems during inspections and managing regulatory crises suggests they can provide strategic guidance beyond documentation services. The cloud-based infrastructure indicates they can support distributed teams and remote collaboration effectively.

Vision28 operates exclusively within the medical device sector of healthcare, concentrating on regulatory compliance and quality assurance rather than clinical operations or healthcare IT. Their expertise spans device classification determination, consensus standards testing requirements, and regulatory pathway selection across FDA, Health Canada, and European regulatory frameworks.

The firm demonstrates deep knowledge of medical device-specific regulations including ISO 13485, ISO 14971 risk management, and FDA 21 CFR Part 820 quality system requirements. Their experience includes devices across the risk spectrum, from simple Class I products like manual toothbrushes to more complex implantable and diagnostic devices requiring extensive regulatory documentation.

The ideal client is a medical device manufacturer in startup or expansion phase seeking FDA 510(k) clearance, quality system establishment, or multi-market regulatory strategy. Companies with Class I or II devices navigating their first regulatory submissions or those facing compliance challenges from FDA inspections would align well with Vision28's expertise. Organizations preferring senior-level consultant engagement over large consulting teams should also consider this firm.