Medical device product and documentation maturity evaluation

Leveraging our deep industry knowledge, we offer a Medical Device Maturity Evaluation service designed to assess the readiness of a product and its documentation. The purpose of medical device product and documentation maturity evaluation service is to review the existing technical file content against required main standard and regulation requirements as well as maturity of manufacturing specification to be able to source and manufacture the product. Evaluation includes review of existing product technical documentation and existing prototype and online workshops with customer to gain further understanding. Review is done from following aspects and provides a report defining feedback of seen maturity level, identification of main gaps and recommendation for corrections. 

This includes: i) technical documentation content and readiness level, ii) product design inputs and requirements, iii) Prototype maturity, iv) Risk management documentation, v) SW development and documentation, iv) Usability engineering documentation, iiv) Verification and validation test documentation, and iiiv) Manufacturing specifications (drawings, electronics documentation, production work instructions, production test specifications). Evaluation starts with a common 1-2 hour kick-off workshop with customer team to review the available documentation content, discuss about already known points and agree on possible particularly desired aspects to consider in evaluation. After kick-off workshop, Innokas team of experts analyse the delivered documentation and organise further 1-2 hour workshops with customer based on need. Typical duration of ‘medical device product and documentation maturity evaluation’ is 1 calendar month.