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In our experience, a product’s success is created at the development and implementation stages. SP Medical ensures that the project process helps make the product a successful one.
We have extensive experience in managing complex projects using our standardized and IT-based project management system (BPM - Business Process Management). We have experience in both large and small outsourcing projects and in the development of new components as well as complete devices.
When a project is launched, we set up a project organization that works on the project throughout its planning, implementation and maintenance stages.
The project organization consists of a project manager and a project team made up of experts in quality management, process engineering, materials properties, automation, tools, construction, design, logistics, sales and other fields.
The project organization employs a systematic and standardized approach that ensures efficient planning, coordination, problem-solving and implementation of the project.
Quality Activity Plan (QAP)
Our project management model includes a Quality Activity Plan (QAP) that defines requirements for the relevant product.
Our QAP takes into account the documentation requirements set out in EUGMP, FDA Part 820 (QSR) and the Medical Device Directive (93/42/EEC).
This means that we prepare documentation in the form of a Design History File (DHF), a Device Master Record (DMR) and a Device History Record (DHR).