Medical Device Consulting
Toltec offers medical device product development and engineering services with a emphasis on effective use of standards and processes that meet FDA and EU regulatory needs.
Theoretical and hands-on expertise in developing and applying Design Control techniques for FDA 21 cfr part 820.30 and ISO 13485 compliance.
Technology selection, trade-off studies, reliability engineering, formal development processes, and project management for medical devices.
Product Development Regulations/Standards
- Design Controls: 21 cfr 820.30
- ISO 13485
- 510k/PMA Submission Regulations: 21 cfr 807, 814
- Combination Product Regulations: 21 cfr 3,4
Technology Experience Examples
- Hemodialysis and other blood processing therapies
- In vitro diagnostic devices (IVDs)
- Heart replacement technologies (LVADs, temporary artificial hearts)
- Combination products
- Expert witness for patent and civil litigation
Human Factors Engineering
Medical Device Safety Standards Expertise
Expertise in the following medical device standards:
- Electrical Safety IEC 60601-1; collateral standards IEC 60601-1-X series; particular standards IEC 60601-2-XX series
- Risk Analysis ISO 14971:2007, EN ISO 14971:2012
- Biocompatility ISO 10993
- Software development IEC 62304
- Human Factors IEC 62366, ANSI AAMI HE-75