“Orcanos QPack Medical™, an ALM 2.0 tool for the Medical Device plays a major role for every regulated organization that is going through audit for any notify body. Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit”
Oren Tamari CEO, Argo Medical ”
Customer: Argo Medical Technologies LTD.
Country: U.S. /Israel
Industry: Medical Device
Argo’s ReWalk™ system provides users with an opportunity to expand their horizons with a new independence. Whether it is going for a walk, talking with friends and family, standing at a stove and cooking, retrieving an item from a high shelf, or getting a hug while standing up, the ReWalk has the potential to make little changes that can have a big impact in people’s lives.
To manage a full Medical Device development process over ONE single tool and to be able to convert business requirements into actual product using single repository for everyone in the organization.
Either for new or existing product the marketing people initiates the development process through executive committee. The R&D department will How QPack was implemented
Key benefits and Results
Argo working with the system for over 1 year, it took about 3 months to get the system ready for the first audit.
- Rapid development
- Full Traceability on the DHF file
- One system with full traceability
- From Business Requirements to Customer Complaints
- Submission of new products done from QPack system
- Audits Internal/External done by the system
International Control over external production plants
Complaints and CAPA are fully traced