FDA and ISO 13485 Compliance

Founder experience

The founder of Tenodon began his medical systems work at Siemens and later helped establish Zoe Medical, a medical device company focused on patient monitoring.

At Zoe Medical, he created and managed a lean quality system designed to meet FDA Quality System Regulation (QSR) and ISO 13485 requirements without unnecessary bureaucracy.

Lean quality systems

The quality system was built for a small team, including only limited QA/RA staffing, while still covering the practical needs of a regulated medical device company.

• Clear procedures that supported engineering rather than slowing it down
• Practical documentation structures that could be maintained by a small team
• Regulatory coverage without unnecessary complexity
• Audit readiness as an ongoing discipline, not a last-minute exercise

Regulatory scope

Experience includes quality system elements spanning the full medical device lifecycle:

• Design controls and traceability
• Document control and change management
• Risk management support
• Supplier and purchasing controls
• Production and process controls
• Complaint handling, CAPA, and post-market surveillance

Audit experience

The quality system was managed through numerous TÜV and FDA audits.

That experience shaped a practical view of compliance: procedures must be clear, records must be complete, and the system must be simple enough that people actually use it.

How Tenodon can help

• Creating or refining quality system procedures
• Aligning engineering work with FDA QSR and ISO 13485 expectations
• Improving design control, traceability, and verification workflows
• Simplifying bloated quality systems that have become hard to maintain
• Preparing for audits and strengthening day-to-day audit readiness

Philosophy

A quality system should help a company build safe and effective products. It should provide discipline, traceability, and accountability — without becoming an obstacle to engineering progress.