Case Study: Long Island Technology Group achieves faster product development and ISO 13485 design-control compliance with Greenlight Guru

Easily Documenting Design Controls to Accelerate Product Development

Long Island Technology Group (LITG), a medical device design, development and contract manufacturing firm led by Allan Katz, needed a simpler, more auditable way to document Design Controls and manage their QMS. They adopted Greenlight Guru’s quality management software/eQMS to help their engineering team—many new to medical devices—capture user needs, design inputs, reviews and traceability without the traditional burden.

Greenlight Guru delivered an easy-to-use eQMS with a design-controls traceability matrix that allowed LITG to review 30–40 linked documents in 15–20 minutes and demonstrate compliance during audits. Using Greenlight Guru, LITG successfully expanded their ISO 13485 scope to include clause 7.3 (auditor evidence reviewed in under 15 minutes), relied on the platform for their product launches, and reduced audit frequency from four times a year to two, accelerating product development and compliance.

Long Island Technology Group

Evan Jones

Product Development Engineer