The changing framework conditions of the market and the regulatory requirements are a particular challenge in the developmentof medical products for trauma surgery.
The OTM team is greatly experienced in the process of approval for the European and American market. We offer our customers a gapless execution of the requirements needed for an EU conformity assessment or a FDA premarket approval.
The corresponding documentation starting with conception stage and ending with the handover to serial production is made up in consideration of ISO 13485 and corresponding standards and made available to our client.
Considered top priorities:
- quality assurance of single components and entire systems
- qualification of testing facilities (IQ/OQ/PQ)
- tests during development
- risk management and risk analysis (FMEA)
- design verification by accredited laboratories
- process validation
- generation and maintenance of the design history file
Furthermore, OTM offers own experience in the field of making up a quality management manual with all the needed work and testing instructions.