Kıyıcık Medikal: ISO 13485 and ISO 14971 set-up

Kıyıcık Medikal was meeting ISO 13485 as a requirement in hospital procurement tenders and exports. The company's production records were good, but its design and development activities and risk management were not tied to a formal file.

Approach

• Product family classification and mapping of regulatory requirements
• Design and development plan, inputs and outputs, verification and validation records
• Risk management plan and per-product risk file according to ISO 14971
• Sterilisation and packaging validation documents and a clean-room monitoring plan
• Complaint and vigilance procedures and a recall plan

Result

The ISO 13485 certificate was obtained at the first audit. In the same year the company met the mandatory requirement in two new hospital tenders and signed contracts.

Lessons

The biggest challenge in medical device projects is creating design and development records retrospectively; for new products this burden was eased by running the process from the start.