June 27, 2025
Review by company with 10-49 people
Timeline
- 17 July 2023 – Contract signed with BSI
- 16 October 2023 – ISO 13485 first audit (completeness of SOPs)
- 22 January 2024 – Initial review of Technical Documentation completeness
- 13 February 2024 – ISO 13485 second audit (records review)
- 4 March 2024 – Technical Documentation review started
- 9 May 2024 – Our responses submitted for first round of queries
- 19 July 2024 – Our responses submitted for second round of queries
- 1 October 2024 – Our responses submitted for third round of queries
- 6 December 2024 – Certificate issued
Cost
Total cost: ~ €100 000